Arl Bio Pharma Jobs in Usa

Technical Writer (Pharma) Job Summary:

A leading global contract development and manufacturing organization (CDMO) in St. Louis, MO is seeking a Technical Writer. This is a contract-to-hire role and it will require you to work onsite five days a week. As a Technical Writer, you will author new and revise existing documents to ensure content accuracy and conformance to established standards. The scope includes, but is not limited to, developing and/or revising standard operating procedures, batch records, forms, and training documents to support aseptic operations.

Technical Writer (Pharma) Responsibilities:

• Write standard operating procedures with appropriate details that are easily understood, readily usable for consistency in training, and conform to company policies and government regulations.
• Develop procedural documents using human performance and technical writing tools that enable right-first-time document execution efficiencies. Regularly monitors department documentation metrics for the purpose of making document improvements to minimize the potential for data entry errors on executable forms.
• Review and analyze new and existing procedures for concurrence with correct department methods through direct observation of aseptic manufacturing processes and interviews with subject matter experts.
• Manage department document projects; ensure project deliverables are completed per the project timeline.
• Draft new and revised SOPs, Batch Records, Forms, and OJT skill assessment documents.
• Leads continuous improvement efforts related to GMP documentation.
• Interact with internal departments to develop new and revised documents. Directly interact with the sites' Manufacturing, Quality, Validation, Regulatory and EHS Departments to ensure document revisions are accurate, executable and comprehendible.
• Track and report document status for key projects.

Technical Writer (Pharma) Qualifications:

• Associates degree in life science, education/training, or other equivalent related discipline.
• 1-2 years pharmaceutical experience.
• Excellent project management and organizational skills including the ability to independently understand, follow, and implement complex instructions and follow assignments through to completion.
• Knowledge of Quality Systems as it relates to GMP documentation requirements.
• Strong technical writing ability with experience writing instructional documents.
• Advanced computer skills that include MS Word, Visio, PowerPoint, Excel, Adobe Acrobat. Ability to work in and create Microsoft Word Templates. Ability to create and revise complex Word documents that include formatting pictures, tables, shapes, and embedded macros.
• Project management and organizational skills.
• Excellent verbal and written communication skills.
• Interpersonal and communication skills required to build and maintain working partnerships with all levels of the organization.

Our client – a global and growing BioPharma CDMO company needs an Engineering Line Lead with Pharmaceutical Industry experienceat their expanding plant in WA state, Excellent total comp. up to $180K+ with excellent Benefits + Relocation Bonus. Client will sponsor for H1B Visa transfer.

Job Posting # 2705R

Job Title: Engineering Team Lead Overnight Travel: 10%

Location: Spokane, WA

Relocation: YES – Theclient offers a lumpsum bonus for relo assistance.

Compensation:Salary range $120K - $165K+ Annual Bonus (10 %)

Full Benefits: Medical, Vision, Dental, 15 days’ vacation/Sick time, 10 - Holidays, 401k (match up to 4%).

Company Info:

Our client is a growing CDMO company in the Pharmaceutical Industry. They are a part of a global parent company with sites in many countries with around 1,300 people at this site in Spokane, WA.

This is an integrated contract development and manufacturing organization (CDMO) offering specialized Aseptic Sterile manufacturing, filling and lyophilization of drug products in Vials.

Group Info: Be part of the Plant Engineering group of around 60 technical people. This role will have 3 people reporting under this person and handle all technical aspects for this new line 3 (note 1 + 2 below)

This role will report to the Engineering Manager.

Note 1: The company recently completed installation of their 3rd state-of-the-art Sterile Liquid compounding & Vial Filling line and are expanding again with a 4th line at this growing plant site.

Note 2: The primary focus will be the technical and project engineering aspects of a complete filling line.

Note 3: Client willsupport transfer of existing H1B Visa for this permanent direct hire role, but will not sponsor for a new H1B visa.

Job Summary:

The Engineering Line Lead position provides leadership, manufacturing support and coordination of the engineering department for the CMO line specific projects.

This position ensures that contract projects, equipment functionality, compliance support, and capital expenditures are executed per Company management initiatives, compliance guidelines, the project management system, and the capital budget schedule.

It is the responsibility of this position to ensure line specific compliance of the CMO equipment and team with state, local, and federal regulations.

This position ensures operations and projects are carried out under adherence to GEPs and cGMPs.

Job Functions and applications in cGMP settings.

1. Provide technical oversight and leadership to the engineering team roles responsible for their area of responsibility within the CMO Business Unit.
2. Drive technical improvements and internal/external responses to equipment and facility observations.
3. Management of the assigned capital project schedules and budgets.
4. Assign and oversee engineering projects including internal capital, compliance, and contract manufacturing.
5. Coordinate and supervise engineering resources to ensure adequate and appropriate staffing for current and upcoming projects.
6. Ensure designated area, equipment and engineering infrastructures are compliant to local, state, federal, and international regulatory agencies.
7. Execute high level projects from conception, consistent with upper management objectives for business growth.
8. Manage and execute facility and equipment updates to meet company growth and economic objectives.
9. Support client audits and technical visits.
10. Effectively communicate project status, constraints and current or potential issues to upper management.

Candidate Must Have:

• Bachelors of Science in Engineering or related technical degree.
• 5+ years of Engineering Experience
• 3+ years of Engineering experience in the BioPharma industry
• 2+ years of Project Engineering/Management experience
• Some Leadership, Supervisory experience over Jr. Engineers, Technicians.
• Facility or Manufacturing Engineering Experience
• MS Office suite (Word, PowerPoint, Excel) experience

Candidate Nice to Have:

• BS in Mechanical, Chemical, Electrical, Manufacturing engineering
• Advanced degree or PE or PMP certification
• Experience with PM Software – MS Project, Design software - AutoCAD & ERP – SAP
• Experience with Pharma sterile aseptic manufacturing, filling, Lyophilization
• Interfacing with OEM equipment vendors, Construction/consulting partners

Keywords: Projects, Plant Project, engineering, Pharma, CDMO, manufacturing, plant, FDA, GMP, Sterile Aseptic liquid filling, Isolators, Clean rooms, Lyophilization, contract Manufacturing, Supervisor, Lead

Community hospital part of system looking to bring on Director Bio-Medical! Sign On Bonus! Full Relocation!

Provides leadership and is responsible for the implementation of the program and services. Participates in defining strategic direction of the Bio-Med program through short and long-term goal setting, technology assessment and planning, medical device integration, operations, risk analysis, security, vendor and contract management, fiduciary responsibilities, and required reporting. Assists leadership with developing and strengthening facility and vendor relationships. Ensures that facility program meets and exceeds regulatory requirements for healthcare technology management. Develops and executes KPI’s.

Education:

• Minimum of Tech School certification or Associate's Degree. Bachelor’s degree in preferred.

Experience:

• 5+ years of previous related experience.

Technical Skills

• Experience with healthcare technology management programs including leadership Medical equipment knowledge (manufacturers, models, modalities, capital planning, etc…)
• Understanding of regulatory requirements for medical devices (CMS, TJC, CLIA, AABB, NRC,State, Local)

Title: Master Production Scheduler

Location: Greater Boston Area, MA (100% onsite)

Employment Type: Contract (6+ months)

Status: Accepting Candidates

About the role

Seeking a scheduling lead to serve as the site’s master production scheduling owner within a manufacturing environment. This role drives alignment across functional schedulers, leads governance forums, and owns scheduling metrics, systems accuracy, and dashboard visibility.

Key Responsibilities

• Serve as Master Production Scheduler, maintaining the site scheduling source of truth
• Lead recurring Scheduling Governance Forums, including agenda, facilitation, documentation, and follow-up
• Develop and own Scheduling KPIs (adherence, stability, execution performance)
• Track and analyze schedule performance trends and drivers of deviation
• Build and maintain Smartsheet workflows and dashboards for scheduling visibility
• Ensure disciplined use and accuracy of Scheduling Systems across function

Qualifications

• Bachelor’s degree in Operations, Supply Chain, Engineering, Business, or related field
• 5+ years of experience in Scheduling, Supply Chain, Manufacturing Operations, or Program Management
• Experience acting as a Central Scheduler, Systems Owner, or Planning Integrator
• Strong experience with Smartsheet
• Pharma experience preferred; manufacturing background required

Compensation (MA Pay Transparency):

• Estimated hourly range: $50–$65/hr (W-2).
• Final rate within this range will be based on skills, experience, and interview results.

Management Consultant – Life Sciences AI and Project Management New York City (Hybrid)

We are seeking an experienced management Consultant (manager level) to support a major pharmaceutical client in enhancing their AI capability and executing a number of enterprise-level initiatives. This hybrid role requires periodic on-site presence (1-2 days per week) in Hudson Yards alongside remote flexibility, with direct engagement at the senior stakeholder level. Initial project is set for 2 years, with planned rollover to other projects with the same client thereafter. Excellent work/life balance (client hours and primarily remote) and exposure to senior decision-makers in a rapidly evolving area.

Key Responsibilities

• Oversee enterprise-level workstreams within a top-10 pharma
• Work closely with senior stakeholders to design and implement plans for integrating AI into operations
• Structure and manage cross-functional initiatives, tracking milestones, managing risks, and driving accountability across teams
• Develop high-quality executive deliverables including presentations, roadmaps, and status reporting materials
• Facilitate working sessions and stakeholder interviews; synthesize findings into clear, actionable recommendations

Required Qualifications

• Must be located in commutable distance to New York, New York, United States
• 7+ years of consulting experience, with demonstrated focus in pharmaceutical, life sciences, or healthcare compliance at the manager level
• Background at a major consultancy (e.g., Deloitte, PwC, Accenture, BCG, or equivalent) required
• Working knowledge of AI tools and their practical application in regulated industry settings
• Exceptional proficiency with Microsoft Office suite, particularly PowerPoint, Excel, and Teams
• Strong executive communication and presentation skills; comfort engaging C-suite and senior leadership audiences
• Proven ability to manage multiple workstreams independently in fast-moving, ambiguous environments

Ideal Candidate A strategic thinker and disciplined project manager who brings a robust consulting skillset and knowledge and interest related to life sciences and AI.

Compensation Very highly competitive; commensurate with experience.

Hello Jobseekers

We are hiring Associate to Sr. Manufacturing Engineer to lead and provide ongoing support through our manufacturing life cycle!

Title : Manufacturing Engineer

Location : Pontiac IL

Duration : 6-12 months

No benefits

Lead PFMEA activities in coordination with product development, quality, and manufacturing engineering teams.

Participate in DFM and DFA activities to define manufacturing processes for new product and product enhancement programs.

Develop manufacturing assembly and test methods to ensure Critical to Quality (CTQ) requirements are met.

Must haves:

Bachelor’s degree at a Minimum

Only Candidates with a Medical Device Background

5+ years of experience working in an FDA/ISO regulated medical device/medical equipment manufacturing environment.

Must have prior NPI Manufacturing and/or Process Development experience, including disposables and capital equipment.

Test Method Validation and Verification (TMV, V&V)

Job Purpose

Responsible for the execution of all aspects of solid-dosage manufacturing which includes, but is not limited to, the dispensing, granulation, sifting, milling, drying, encapsulation, coating, compression, and cleaning related activities. Must be able to interact daily with all site support personnel as required. Must be able to complete all required batch record documentation in a thorough, accurate, and legible manner in English. Must be capable of reading and understanding all documented Standard Operating Procedures in English plus demonstrate competency through action and written evaluation.

Essential Duties and Responsibilities include the following. Other duties may be assigned:

• Assist Production Management with all scheduled and requested activities in an efficient and smooth operation.
• Ensure all scheduled commercial and non-commercial manufacturing activities are completed on time.
• Become proficient in the setup, operation, and cleaning of all cGMP equipment used during production operations.
• Participate in all Quality Investigations as required.
• Adhere to all approved Standard Operating Procedures, Batch Records, and Safety Procedures as written when performing all daily activities.
• Ensure the cGMP area is cleaned and maintained following all SOP’s and good housekeeping practices.
• Must use required PPE during cGMP activities as specified in the Batch Records and Safety Data Sheets.

To perform this job successfully, an individual should have:

• Familiarity with working in a regulated pharmaceutical solid dosage facility.
• Ability to read and write documents written in English.
• Excellent written communication skills.
• Familiarity with various cGMP solid dosage Pharmaceutical manufacturing equipment. Able to setup, operate clean, and troubleshoot the solid dosage Pharmaceutical manufacturing equipment being used.
• Able to work with minimal supervision.
• Able to stand on feet throughout an eight-hour work day.
• Able to lift up to 30 Ibs (14 Kgs) without assistance.
• Maintain personal hygiene habits consistent with working in a cGMP environment
• Be capable of wearing all required PPE; including partial and full facepieces based on OSHA guidelines.

Education :

High School Diploma or GED Equivalent.

Bachelor’s degree in Physical Sciences or Pharmaceutical life science related field of study.

Years of related experience

2-8 years related experience in cGMP production operation activities.

Must have Valid work permit.

JOB TITLE: Senior Rebate Analyst

LOCATION: Weston, FLHybrid

SCHEDULE: Monday - Friday | 8:30 AM - 5:30 PM

DESCRIPTION:

A leading organization in a highly regulated industry is seeking a Senior Rebate Analyst to support its Finance team. This role is responsible for managing and analyzing customer rebates, discounts, and allowances while ensuring contractual accuracy, financial integrity, and regulatory compliance.

The ideal candidate brings strong rebate experience, analytical expertise, and the ability to translate complex agreements into accurate financial reporting and actionable insights.

KEY RESPONSIBILITIES:

• Analyze and validate customer rebates, discounts, and allowances.
• Interpret customer contracts to ensure accurate calculations and payments.
• Support rebate forecasting, accruals, and month-end close processes.
• Prepare variance analysis and executive-level financial reporting.
• Perform GL reconciliations and maintain accurate rebate tracking.
• Partner with Accounting, Audit, Government Pricing, and Commercial teams.
• Assist with audit support and regulatory compliance requirements.
• Identify and implement process improvements within rebate operations.
• Mentor junior analysts and serve as a subject matter expert.

REQUIREMENTS:

• Education: Bachelor’s degree in Accounting or Finance.
• Experience:8+ years of rebate and financial analysis experience within a regulated environment.
• Pharmaceutical rebate experience strongly preferred.
• Skills:Strong Excel and Microsoft Office proficiency.
• Solid understanding of contracting and chargeback processes.
• Excellent analytical, organizational, and communication skills.
• Ability to manage multiple priorities and handle confidential information with integrity.

At ttg, "We believe in making a difference One Person at a Time," ttg OPT.

Project Overview

This project involves gutting an existing office space and converting it into an expanded pharmaceutical manufacturing suite. The end state will be a GMP-compliant manufacturing environment. The company is acting as the General Contractor, overseeing architectural, mechanical, and electrical scopes.

Position Summary

The Site Superintendent will serve as the on-site lead, managing all day-to-day construction activities and subcontractor coordination while ensuring safety, schedule adherence, and quality execution. This role will work closely with a Project Manager who will be on site three days per week, along with additional leadership support visiting weekly.

This is a highly visible role with direct owner interaction, and strong performance could lead to future project opportunities or a potential long-term role as additional work is awarded.

Key Responsibilities

• Manage daily on-site construction activities while acting as the primary field representative for the General Contractor
• Coordinate and oversee architectural, mechanical, and electrical subcontractors
• Enforce site safety standards and maintain OSHA compliance
• Manage day-to-day permits, inspections, and owner-required documentation
• Serve as the primary point of contact with the owner, maintaining professional and clear communication
• Track progress against schedule and proactively address field issues
• Ensure work is executed in alignment with pharmaceutical/GMP expectations
• Collaborate closely with the Project Manager (on site 3 days/week) and senior leadership support (1 day/week on site)

Pre‑Construction / Onboarding Expectations

• One week of onboarding in the Raleigh office prior to mobilization
• Review drawings, scope, schedule, and project expectations
• Flexible hours during onboarding week
• Company support available for travel costs; per diem can be built into the model if needed

Required Qualifications

• OSHA 30 Certification
• 10+ years of experience as a Site Superintendent or similar role
• Proven experience managing multi-discipline construction projects up to $5M
• Pharmaceutical or GMP project experience
• Strong mechanical background (preferred discipline)
• Experience working with mechanical and electrical contractors on complex builds
• Ability to confidently interface with owners and stakeholders
• Local to the project area (no per diem offered)

The Department of Biomedical Sciences invites applications for the Dr. Richard J. Bellucci Postdoctoral Fellowship. This Fellowship is one of the most prestigious offered by Creighton University and is reserved for highly promising early-career scientists who are engaged in hearing research. A successful candidate will be expected to conduct leading research in hearing science, mentor junior trainees, and develop a strong publication and presentation record.

We offer:

• Exceptional faculty and mentorship
• Numerous internal funding opportunities
• A strong University benefits package

Qualifications:

• Terminal degree (PhD and/or MD) with extensive, demonstrated experience in any of the following fields: Neuroscience, Chemistry, Developmental Biology, Bioinformatics or other related fields
• A commitment to hearing research
• Excellent communication skills, oral and written
• Strong publication and conference record
• Enthusiasm to work in a highly diverse, collaborative environment

Applicants must provide:

1. A ONE-page essay demonstrating their commitment to hearing research and a project that merits this Fellowship. This essay should include:
   1. A preliminary research plan, hypothesis, or major question.
   2. A member of Center faculty whose lab is appropriate for their research interest.
      1. Applicants are strongly encouraged to contact their proposed mentor in advance of applying to discuss their proposal. Current Center Faculty: Drs. Peter Steyger, David He, Marisa Zallocchi, Litao Tao, Justine Renauld, Jemma Webber, Allison Coffin, Kelsey Anbul, and Hui Hong

2. A biosketch (e.g., NIH Biosketch) that includes tangible products that support your appointment. These may include but are not limited to: Publications, Grant applications submitted and grants received, Patents, Podium and poster presentations, Professional development and career preparation, Volunteer experience

3. Names and contact emails of three professional referees who can provide a confidential letter of recommendation that speaks to their ability to conduct exceptional postdoctoral hearing research at a leading auditory-vestibular neuroscience institution. At least one referee should be outside the applicant's current institution.

Incomplete applications will not be considered.

The Dr. Richard J. Bellucci Translational Hearing Center is based on a highly collaborative and multi-disciplinary research model. We therefore welcome applicants who bring a broad range of applicable skills and perspectives to the Center as they fuel our innovation.

Under general supervision, provides a wide variety of moderately complex laboratory testing and technical lab support for a research facility. Requires knowledge of the processes/procedures in testing, documenting experiments, maintaining laboratory notebook, analyzing data, and reporting using complex statistical computer software.

Qualifications:

Bachelor's degree in related field of Science required;
2-4 year's research lab experience

Knowledge, Skills, Abilities:

Understanding of research methods, laboratory techniques, and care of laboratory equipment;

Ability to interpret data, troubleshoot and resolve technical issues;

Proficiency in Microsoft Office Suite to include Word, Excel; PowerPoint and Outlook;

Detail oriented;

Analytical skills;

Strong work ethic, excellent written and communication skills, and the ability to work independently;

Ability to work evenings, weekends, and holidays depending upon research needs

Physical Requirements:

Seeing: 75 - 100%

Hearing: 50 - 74%

Standing/Climbing/Mobility: 50 - 74%

Lifting/Pulling/Pushing: 25 - 49 % (pound: 15 lbs.)

Fingering/Grasping/Feeling: 75-100%

Travel: No

Exposure to Blood Borne pathogens: No and Yes

AAP/EEO Statement:

Creighton University is committed to providing a safe and non-discriminatory educational and employment environment. The University admits qualified students, hires qualified employees and accepts patients for treatment without regard to race, color, religion, sex, marital status, national origin, age, disability, citizenship, sexual orientation, gender identity, gender expression, veteran status, or other status protected by law. Its education and employment policies, scholarship and loan programs, and other programs and activities, are administered without unlawful discrimination.

Disclosure Statement:

This description describes the general nature of work to be performed and does not include an exhaustive list of all duties, skills, or abilities required. Regular, reliable attendance is an essential function and all employees are required to follow any other job-related instructions and to perform any other job-related duties as requested by their supervisor. Employees may also be required to work in excess of normal working hours as workloads and seasonal activities necessitate. A complete description is available in the Human Resource office located at 3006 Webster Street Omaha, NE. Creighton University reserves the right to modify duties, responsibilities and activities at any time with or without notice.

Class of 2026 welcome to apply!

Backed by global venture capital investors, Harba Solutions is a high-growth consultancy specializing in talent solutions for the Life Sciences industry. We partner with leading Pharmaceutical and Biotechnology organizations nationwide to build high-impact teams that drive innovation and deliver results.

As a sales-driven organization, we provide a comprehensive range of workforce solutions, including Project Consulting and Delivery, Advisory Solutions, Contractor Engagement, Direct Hire, Contract-to-Hire, and Embedded & On-Demand Project RPO services.

For ambitious graduates and early-career professionals, Harba Solutions offers clear pathways into Sales Management, Account Management, and Professional Recruiting. Joining our team means becoming part of a fast-paced, performance-oriented environment with significant opportunities for career advancement in a hyper-growth company.

Job Description

Within this position, you will be responsible for the full life cycle of our scientific recruitment operations. You will be partnering with various Bio Pharma & Bio Tech companies across the country, to deliver our tailored strategies and best solutions to our clients. It is your responsibility to recruit and build relationships with the top talent in our carefully selected markets. This is a pathway to sales management, account management, or professional recruitment roles within a growing organization.

Job Requirements

• Bachelor’s degree
• Have a genuine passion for entrepreneurship, recruiting, and sales
• High level of business acumen
• Embrace learning and staying curious
• Having excellent interpersonal skills and the ability to empathize
• Competition driven
• Ability to work in an office within a team environment

Compensation Package

• Salary + Commission
• Top-tier competitive commission structure
• Detailed Promotion Planning resulting in higher salaries and title changes
• Health, vision, and dental benefits
• Paid time-off
• Holiday pay

Lead Projects that Matter. Build a Career That Inspires. At InServ, our core value is simple: People, First. We prioritize our teammates and empower you to bring your unique insights and ideas to work every day. If you’re ready to take ownership of complex industrial projects and make a real impact, this is your opportunity.

We’re looking for a Senior Project Manager to join our Process Services team: a collaborative, entrepreneurial environment where your leadership drives success. In this role, you’ll be responsible for advancing the development, strategy and lifecycle management of multiple projects simultaneously. Your leadership will ensure successful project outcomes measured by profitability, labor efficiency, safety performance, equipment utilization, cash flow, and quality standards, all reflected in exceptional client satisfaction.

WHAT YOU'LL DO:

• Manage fabrication and installation of Process Piping, Utility Piping, HVAC, Plumbing, Structural Steel, Equipment Setting, and Medical Gas systems to ensure they’re on time, on budget, and to code.
• Champion safety for Healthcare, Industrial, and Bio-Pharma facilities. Enforce safety standards through meetings, investigations, and employee engagement.
• Review estimates and establish job costing systems for labor, materials, and subcontractors.
• Negotiate and prepare vendor/subcontractor purchase orders; review submittals for compliance with contract specifications.
• Conduct monthly cost reviews and progress reports to identify deviations early and ensure timely, budget-compliant delivery.
• Build and maintain strong relationships with general contractors, subcontractors, vendors, and internal teams.
• Oversee all aspects of project planning and execution, including customer meetings for pre-planning, estimating and scheduling, site visits and quality control and cost tracking and change management.
• Prepare and submit purchase orders, accounts payable, and billing promptly.
• Troubleshoot installation issues and maintain client satisfaction.

WHAT WE'RE LOOKING FOR:

• 10+ years of project management experience in process mechanical subcontracting (Process Piping, HVAC, Plumbing, Structural Steel, and Equipment Setting).
• Proven success managing large-scale projects ($5M+).
• Bachelor’s degree in engineering, construction management, or equivalent experience.
• Demonstrated planning and organizational abilities to manage multiple projects.
• Excellent verbal and written communication skills.
• Technical proficiency in relevant disciplines.
• Ability to conduct site visits and review job cost reports for effective project control.
• Proficiency in Microsoft Office and project management software.
• Leadership, coaching, and mentoring capabilities.
• Creative problem-solving and root cause analysis skills.
• Strong negotiation and conflict resolution abilities.
• Flexibility to adapt to changing priorities and conditions.

Travel: Approximately 30% per month, depending on project needs.

Pay range and compensation package:

• Competitive pay that rewards your impact
• Professional development and continuous learning opportunities
• 401(k)
• Health, Dental and Vision Insurance
• Paid Time Off (PTO)
• Tuition reimbursement

Company Overview:

Founded in 1992, InServ is a full-service industrial contractor serving the life sciences, advanced manufacturing, and food and beverage sectors. We specialize in mechanical, electrical and instrumentation, hygienic piping and HVAC trades. Operating from multiple locations across North Carolina, we serve clients throughout the Southeast. Our success is built on an unwavering commitment to safety, quality, and schedule adherence.

Equal Opportunity Statement: InServ is proud to be an equal opportunity employer committed to building a diverse and inclusive workforce. We consider all qualified applicants without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, genetic information, or any other characteristic protected by law.

Amber Bio is a biotechnology company pioneering new gene editing modalities using multi-kilobase edits to reach previously undruggable patient populations. Founded by pioneers in the CRISPR field from leading institutions for gene editing research, the company is developing a first-of-its-kind RNA editing platform that can correct thousands of bases at once, thereby correcting genetic mutations safely and reversibly. Multiple openings are available on a rapidly growing team. If you are interested in building a new frontier in genetic medicine, please apply via LinkedIn.

Job Description: Associate Director or Director, Nonclinical Development

Position Overview:

We are seeking an experienced and highly motivated Director of Nonclinical Development to lead preclinical activities supporting our RNA editing pipeline. The successful candidate will design and oversee nonclinical pharmacology, biodistribution, and toxicology studies, ensuring timely and high-quality execution to support IND submissions. Reporting into the VP of Development, the candidate will provide both strategic leadership and hands-on management in a fast-paced startup environment, partnering closely with discovery, analytical, and manufacturing teams.

Key Responsibilities:

• Study Design & Oversight
• Design, oversee, and interpret preclinical studies (non-GLP and GLP), including pharmacology, biodistribution, and toxicology studies
• Select, negotiate, and manage CROs and external partners
• Write, review, and edit preclinical study reports and nonclinical sections of regulatory submissions
• Ensure data, methods, studies, and reports meet FDA, EMA, and ICH guidelines
• Strategic Leadership
• Define and implement the nonclinical development strategy for RNA editing programs from candidate selection through IND submission
• Identify key risks, mitigation strategies, and timelines for nonclinical workstreams
• Maintain up-to-date knowledge of regulatory guidance and emerging science in RNA editing, gene therapy, and AAV biology
• Collaboration & Communication
• Partner with discovery scientists to inform candidate selection strategy
• Work with manufacturing and analytical teams to ensure efficient hand-offs and successful integration of data across functions
• Communicate findings and recommendations clearly to project teams, leadership, and external stakeholders

Qualifications:

• PhD in Pharmacology, Toxicology, Biology, or related discipline
• At least 5 years in a biotech/pharma environment
• Experience in drug development for ocular and CNS indications
• Demonstrated track record of designing, monitoring, and interpreting preclinical safety & efficacy studies for IND submissions
• Strong understanding of FDA and ICH guidance on gene therapy
• Proven success in managing CROs and vendors for GLP/non-GLP studies
• Experience integrating nonclinical data into regulatory submissions
• Ability to synthesize complex data sets and communicate effectively across functions
• Ability to travel up to 25% of the time

Preference will be given to those who display:

• High motivation, with a strong work ethic and dedication to generating impact
• Attention to detail, with the ability to extract deep insights from data
• Ability to go from ideation to data in an independent fashion
• Long-term personal vision with defined career goals
• Team-oriented thinking
• Demonstrated excellence in small team environments, including a “no task is too small” attitude

If you have a passion for advancing gene editing technologies and desire to be part of a pioneering biotech company, we encourage you to apply and join our ambitious team.

Please apply directly through LinkedIn.

Amber Bio is an equal-opportunity employer and encourages applications from candidates of diverse backgrounds. We value diversity and are committed to creating an inclusive and supportive work environment for all employees.

JOB DESCRIPTION

The Research and Development Operator I would operate, clean, disassemble, and reassemble equipment such as blending, granulation, compression, and coating machinery in accordance with applicable cGMP and SOPs. In this role, the incumbent would rotate between Pilot Plant and Manufacturing departments as determined by the needs of the business.

Essential Duties & Responsibilities

• Proficiently operate, disassemble, assemble, and clean equipment.
• Operate, disassemble, assemble, and clean equipment in other departments proficiently.
• Routinely perform housekeeping assignments, maintain cleanliness and routine maintenance of the work area and equipment.
• Uses computer to read, review, and train on SOPs.
• Review current SOPs and provide feedback on potential process improvements.
• Participate in work scheduling. Handle computer transactions/metrics for the department.
• Record operating data within batch records in accordance with cGDP.
• Review and record completed production documentation (batch records, logbooks, etc.) for quality and cGMP compliance.
• Able to troubleshoot production processes and notify applicable parties for assistance.
• Recognize and report manufacturing incidents. Support investigations and support CAPA’s on occasions.
• Builds productive, trusting, and respectful relationships at all levels in the organization and must consistently act as a team player.
• Collaborate effectively and communicate with other functional groups, including quality, validation, and supply chain to ensure production goals are achieved.
• Follows Piramal Pharma Solutions Safety, Health, and Environmental policies and procedures.
• Maintain confidentiality for all clients and activities in the development process.
• Performs other duties as assigned or as business needs require.

Requirements

• High school diploma or GED required.
• Individuals with equivalent education, training, and experience will be considered.
• Experience in a pharmaceutical, chemical, biochemical, or food manufacturing environment required.
• 2+ years working within an industrial or manufacturing environment preferred.

Physical Requirements

• Lift up to 40 lbs. and occasionally move drums weighing up to 300 lbs.
• Able to work safely with heavy equipment.
• Regularly stand, walk, sit, use hands to finger, feel objects, tools, controls, reach with hand and arms, talk, hear, and good vision.
• Ability to climb ladders, bend, stoop, and kneel.
• Individual may be required to wear Personal Protection Equipment including N95 respirators and Powered Air Purifying Respirators.
• Not allergic to chemicals or bio-substances found in laboratory or production facilities.

Sr. Associate

Thousand Oaks, CA (Onsite)

1 Year Initial Contract

Pay: $26/hr

Job Details: To perform experiments, organize data and analyze results under minimal supervision. With minimal supervision, plans, conducts or monitors experiments, records and organizes data, analyses results, generates robust and reliable data and/or Ensures that contracted studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Responsibilities include:

? Monitors or follows established experimental design and protocols and performs routine tasks and studies to obtain reproducible and reliable results with limited supervision

? Plans, monitors or conducts, analyzes and records experiments, and provides interpretation of data

? Develops and implements new protocols with moderate review

? Engages coworkers in scientific discussions

? Communicates data and interpretation to work group

? Skilled at developing systems to ensure quality data

? Skilled and/or knowledgeable in the use of standard laboratory equipment and with one or more major laboratory instruments/techniques

? Effectively trouble-shoots equipment and experimental difficulties ? Contributes to internal/external reports, papers, presentations, regulatory documents, invention disclosure submissions and/or patents

? Participates in department-wide support efforts such as safety, recruiting and committees

? May train staff and/or supervise others

? Coordinates and organizes resources needed to complete the task

? Understands when to seek input and when to make independent judgments

Day to Day Responsibilities:

Lab-based position. Responsible for sample analysis with a variety of analytical techniques (LC, CE, particle analysis, compendial methods). Responsible for supporting the timely execution of process related experiments to enable tech transfers to manufacturing sites. Candidate will be required to document study/analysis execution and interpret/present results and conclusions. Participate in team/group meetings.

Requirements:

• Degree in Biology, Biochemistry or Analytical Chemistry or related field
• Experience in a Biopharmaceutical working environment
• Experience with typical bio characterization techniques such as liquid chromatography techniques, capillary electrophoresis including troubleshooting strongly preferred.
• Good interpersonal skills, the candidate will be working in a very team-focused environment. Familiarity/experience with biologic process development.

JOB OVERVIEW

Reporting to the Sr. Manager, EHS, the EHS Associate position supports all areas of Environment, Health, and Safety with a focus on waste management, emergency response programs, and regulatory compliance.

PRIMARY RESPONSIBILITIES

• Demonstrate environmental, health, and safety (EHS) expertise while fostering a culture of safety excellence and proactive commitment to workplace well-being.
• Drives conformance to the site’s EHS management system
• Establish effective programs, communications, and procedures that meet regulatory requirements and align with Piramal EHS Guidelines.
• Manage waste and recycling programs in accordance with DEP, DOT, RCRA, and EPA requirements through internal procedures, training, and coordination of vendors.
• Provide support for sitewide EHS leading and lagging indicator programs, with a drive to CAPA completion and achievement of EHS sitewide and corporate goals.
• Identify and assess workplace hazards, implementing necessary measures to minimize risks.
• Sustain Occupational Health programs both in-house and contracted.
• Perform periodic workplace inspections, audits and hazard assessments.
• Keep site emergency response procedures up to date, conduct training and drills.
• Participate and foster growth in Site Safety Committee.
• Support ESG and sustainability goals.
• Maintain personal protective equipment (PPE) hazard assessment program and inventories.
• Demonstrate financial stewardship.

QUALIFICATIONS/REQUIREMENTS

• Minimum of Associated Degree, Bachelor’s preferred, in a scientific discipline, Health and Safety or Environmental Science preferred, with 3-5 years experience in the EHS field.
• Experience in hazardous and non-hazardous waste management.
• Solid understanding of OSHA regulations with training development and delivery competency.
• Working knowledge of spill response and management techniques.
• Must possess problem solving, logic, and critical thinking skills and the ability to make sound, risk-based decisions.
• Must be able to work in a team environment with effective project planning/management, organization, and execution skills.
• Must have proficiency in the Microsoft Office Suite programs.
• Excellent oral and written communication skills.
• Ability to work effectively managing multiple projects independently with cross-functional departments and manage priorities to meet timelines.
• Must be innovative, proactive, resourceful and committed to continuous improvement.

WORK ENVIRONMENT

The position requires the ability to work in office and manufacturing settings with time spent performing “on the floor” activities in laboratory and manufacturing areas, as well as outdoor activities such as water sampling and roof inspections. Generally a day shift position, but may require very occasional overtime, evening, or weekend work with an ability to be reached after hours in case of emergency.

PHYSICAL REQUIREMENTS

• Lift up to 40 lbs.
• Able to work safely with heavy equipment.
• Regularly stand, walk, sit, use hands and fingers, feel objects, tools, controls, reach with hand and arms, talk, hear, and good vision.
• Ability to climb ladders, bend, stoop, and kneel.
• Individual may be required to wear Personal Protection Equipment including N95 respirators and Powered Air Purifying Respirators.
• Not allergic to chemicals or bio-substances found in laboratory or production facilities.

Company Description

Bird Dog Pharma helps medical practices seamlessly integrate physician-directed allergy care into their routine clinical workflows, ensuring continuity of care for patients. Focused on empowering practices to address allergy-driven conditions such as asthma, eczema, and sinus complaints, Bird Dog Pharma supports providers with in-office testing, personalized immunotherapy, and operational integration. By simplifying allergy care, we enable physicians to deliver comprehensive treatment within their own offices. Our mission is to make allergy care practical, sustainable, and accessible for healthcare providers.

Role Description

This is a contract, remote position for a Medical Sales Representative. The role involves engaging with medical practices to promote and support the adoption of Bird Dog Pharma's allergy care solutions. Responsibilities include building and maintaining client relationships, educating healthcare professionals on the company's offerings, and identifying opportunities to expand sales territories. The ideal candidate will conduct market research, provide customer service to medical providers, and achieve sales goals while maintaining a consultative approach.

Qualifications

• Proven experience in Medical Sales and a track record of meeting or exceeding sales targets
• Strong Communication and Customer Service skills for building relationships and delivering excellent support
• Knowledge of Medicine and Pharmacy principles, with a focus on allergy care or a related field
• Self-motivated with the ability to work independently in a remote capacity
• Experience working with healthcare professionals or within a clinical environment is preferred
• Strong organizational skills and adaptability to meet the needs of a fast-paced, dynamic role

Job Summary:

To provide product management, modeling and commercial analytics to support PAI’s strategic product development and life cycle management. This role will manage the functions including product forecasting, 5YSP/Budget, competitive analytics, business management and insights reporting and product launch coordination to support growth and sales operations.

• Responsible for supporting business case development, business development modeling, and modeling new product targets

• Responsible for performing commercial analytics, insight generation and competitive analysis

• Supports launch planning

• Contributes to Finance quarterly planning cycle for 5YSP/Budget

• Supports portfolio sales economics

• Provides holistic support to Finance & Leadership teams

Duties and Responsibilities:

1. Lead commercial business insights and reporting to support growth and commercial execution, to include but not limited to competitive and market share analysis, business and competitive intelligence reporting, product performance and ad-hoc.

2. Lead the product forecasting/modeling for all commercial products which supports business case development, demand planning, manufacturing readiness, and financial budgeting.

3. Contributes to finance quarterly planning cycle, including owning commercial re-forecasting model and supporting portfolio sales economics.

4. Manages various in support of overall analysis of PAI Pharma’s revenue, including holistic support of the finance and leadership teams in understanding portfolio changes, even those driven outside the commercial team (BD, R&D, etc.)

5. Delivers adhoc analysis in conjunction with finance team in support of commercial, executive, & finance leadership

6. Be the product expert.

7. Support the development of marketing materials to support existing and new product launches, including sell sheets, product catalog, PR, advertising, podium, white papers, etc.

8. Support and coordinate the execution of new product launch plans.

9. Support commercial and market assessment to drive execution of new product launches and achieve product targets.

10. Support the management and reporting of pipeline postmortem and launch success tracking.

11. Nurtures a team environment of accountability, continuous improvement and best-in-class performance.

12. Assist and manage projects to meet organizational and customer requirements.

ACCOUNTABILITY

For the accuracy and timeliness of all work performed.

SUPERVISORY RESPONSIBILITIES

Manage the product management for assigned products and business analytics process to drive commercial execution.

Education and Experience:

Proven working experience in marketing and product management, preferably in the generic pharmaceutical industry

• Working knowledge of data management and business analytics to derive business and competitive insights

• Ability to think strategically and to lead

• Strong client-facing and communication skills

• Advanced troubleshooting and multi-tasking skills

• Skilled in Excel, PowerPoint and Word

• Solid proficiency and knowledge of commonly used pharmaceutical industry databases like IQVIA, ProspectoRx, First Databank, etc.

• Knowledge of FDA websites

• BS degree in Business Administration or related field

• Minimum 5-7 years of industry related experience

The pay range for this position at commencement of employment is expected to be between $100,000-$140,000; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided to employees who receive an offer of employment.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Physical Requirements/ Working Conditions:

EQUIPMENT AND MACHINES

Personal computer and standard office equipment.

WORKING CONDITIONS

Office environment. Occasional business travel may be required.

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. PAI uses E-Verify.

PAI Pharma is a nicotine-free campus, meaning the use of nicotine products—including cigarettes, vaping, chewing tobacco, and any other nicotine-containing substances—is strictly prohibited on company property. All employees should be able to complete their full shift without the need to use nicotine. By joining PAI Pharma, you agree to adhere to our nicotine-free workplace policy, which supports a healthier environment for all employees.

EEO Employer / Veteran / Disabled

Position Summary:

The Associate Director, Quality Control will be responsible for providing strategic, scientific, and operational leadership for the development, qualification, validation, and lifecycle management of analytical methods supporting Upstream Bio’s lead program verekitug. This role will manage and execute GMP quality control (QC) activities directly related to batch release for clinical trial material supply. The leader in this role must assure that quality controls for investigational new drugs (investigational medicinal products) meet all quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations. The Associate Director will report to Senior Director of Analytical and serve as a key partner to Quality, CMC, Regulatory, and cross-functional teams. This individual will provide technical guidance and business acumen to ensure execution of analytical activities for late-stage programs through BLA/MAA submission, approval, and commercial launch.

Key Responsibilities:

• Author, review and approve analytical method procedures/SOPs
• Author, review and approve analytical method transfer/qualification/validation protocols and reports
• Manage external CDMOs and CROs to execute Development and GMP release and stability testing of Drug Substance and Drug Product in a compliant-manner
• Establish and manage reference standard and critical reagent programs
• Participate in the laboratory quality system activities such as internal audits, writing standard operating procedures, and documentation review.
• Perform data verification and audits in order to ensure accuracy of data and analytical processes.
• Ensure compliance with company policies and SOPs as well as global health authority guidelines.
• Create, analyze, verify, and approve QC data such as method validation, release and stability, results, reports, and Certificates of Analysis (COAs).
• Generate, review, and revise specifications, SOPs, and other QC laboratory and testing documentation.
• Lead Out-of-Specification (OOS), Out-of-Trend (OOT), and Deviation investigations related to the QC laboratory and ensure effective corrective and preventive actions (CAPAs) are implemented.

Qualifications:

• Experience in stability study performance/evaluation and/or knowledge/familiarity with USP/compendial testing is helpful.
• Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential.
• Proficiency with Microsoft software (Word / EXCEL / PowerPoint), Stability software and statistical analysis/trending to support shelf life and labeling is expected.

Knowledge and skills (general and technical) preferred:

• Broad background, strong comprehension, and demonstrated skills in analytical methods development/validation/transfer/similar, reference standards characterization/structural elucidation, and unknown identification.

Education level and/or relevant experience required:

• Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 10+ years of demonstrated success in leading cross-functional teams and managing projects along with 7+ years relevant analytical experience in a cGMP-compliant pharmaceutical laboratory environment. Any ASQ or other certifications is a plus.

About Upstream Bio:

Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at .

Compensation

Target Salary Range: $176,400 - $215,600

*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience. Base pay is only one component of the company’s total rewards package. All regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.