Keysource Pharmaceuticals Jobs in Usa

SUMMARY/OBJECTIVE:

The Senior Director, Operations is responsible for leading day-to-day operational execution across manufacturing, packaging, project management, facilities, and warehouse functions within a cGMP, CDMO, or CMO environment. This role translates company strategy into operational plans, drives performance against key metrics, and ensures safe, compliant, and efficient delivery of client programs. The Senior Director partners closely with Quality, Research & Development, Operations, Logistics, Finance and Business Development to support growth, client satisfaction, and inspection readiness.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provide operational leadership and oversight for both U.S. and Ireland-based operations teams, ensuring alignment of processes, priorities, and performance expectations across sites.
• Lead daily operations across manufacturing and packaging services, ensuring schedule adherence, quality, and throughput.
• Own operational performance metrics (e.g., OTIF, right-first-time, labor utilization, cost control, and equipment performance).
• Translate strategic objectives from executive leadership into executable operational plans and priorities.
• Provide leadership and development for operations managers and cross-functional teams.
• Partner with Project Management to align production schedules with client timelines and contractual commitments.
• Ensure compliance with cGMP, FDA, DEA (as applicable), and company quality systems; support internal and external audits.
• Drive continuous improvement and operational excellence initiatives, including lean practices and waste reduction.
• Collaborate with Quality on deviation investigations, CAPAs, and risk mitigation actions.
• Support client onboarding, tech transfer, and scale-up activities to ensure successful execution.
• Work with Facilities and Engineering to optimize equipment utilization, maintenance planning, and capacity expansion.
• Collaborate with Warehouse teams to ensure material availability and inventory accuracy.
• Provide operational input during new business assessments and client proposals.
• Maintain effective communication with senior leadership on performance, risks, and resource needs.
• Comply with all company and site policies and procedures and perform other duties as assigned

QUALIFICATIONS AND EXPERIENCE:

• Bachelor’s degree required (Engineering, Life Sciences, or related field preferred).
• 8–12+ years of experience in cGMP pharmaceutical manufacturing and/or packaging environments, including at least 5 years supporting clinical and commercial manufacturing and packaging operations.
• 5+ years of progressive leadership experience managing operations teams.
• Experience in a CDMO/CMO or multi-client manufacturing environment required.
• Demonstrated success leading regulatory inspections and client audits.
• Strong understanding of pharmaceutical packaging, production planning, and operational controls.

COMPETENCIES/SKILLS:

• Strong operational leadership and execution mindset.
• Excellent analytical, problem-solving, and decision-making skills.
• Ability to interpret data and drive performance improvements.
• Effective communication and stakeholder management skills.
• Financial acumen with experience managing budgets and operational costs.
• Ability to lead cross-functional teams in a fast-paced CDMO environment.
• High integrity, professionalism, and accountability

SUPERVISORY RESPONSIBILITIES:

Yes. Typically includes Production/Packaging Managers, Warehouse leadership, Facilities leadership, Project Management and other operations personnel as assigned.

WORK ENVIRONMENT:

Hybrid office and manufacturing environment; routine presence on the production floor required.

SCHEDULE:

On-site 5 days per week in Cranbury, NJ office

SALARY:

$190,000 - $240,000

PHYSICAL DEMANDS:

Combination of office-based work and time in warehouse/manufacturing areas. Ability to stand, walk, and move through production areas as needed.

TRAVEL:

Up to 20–30% travel may be required based on client and business needs.

Title: Clinical Laboratory Assistant

Machaon Diagnostics is a clinical reference laboratory, specializing in the diagnosis, treatment and monitoring of hemostatic and thrombotic conditions. We are looking for a passionate, intellectually hungry, recent college graduate interested in gaining clinical laboratory, contract research, and clinical trial experience to fill our laboratory assistant job opening. Past laboratory assistants have had the opportunity to enter into CLS, MD, PharmD and other allied health graduate programs.

Job Details: Demonstrate proficiency and understanding of standard clinical laboratory practices. Review requisitions, orders tests and processes specimens in preparation for laboratory procedures. Perform general laboratory maintenance tasks including preparing reagents, re-stocking consumables and washing glassware. Assist with quality control and quality assurance paperwork. Assist with clinical trials including completion of Institutional Review Board documentation, subject recruitment, screening, and management, and performance of research related testing. Design and revise forms and protocols. Adhere to Machaon policies and procedures as directed by the supervisor, manager or medical director. Interact with patients, subjects, visitors, physicians, and coworkers in a professional and courteous manner. 

Qualifications:

-B.A./B.S with coursework in chemistry, biochemistry, immunology, molecular biology, statistics and related subjects required.   

-6 months or more related experience preferred.

-Strong organizational skills

-Strong communication skills

-Proficiency in MS Excel, including statistical applications

-Must reside locally

Please send resume and cover letter via e-mail to:

The laboratory is in Berkeley in the sunny San Francisco East Bay, just 11 miles from downtown San Francisco. We are easily accessible by BART, buses and other mass transit.

Machaon is a fun, fast-paced and challenging environment that delivers specialized clinical reference lab testing services to doctors and hospitals across the US. We also conduct contract research/ clinical trials for the pharmaceutical and biotech industries, making the workload dynamic. Machaon Diagnostics was founded in 2003 by a team of CLSs and we invite you to learn from our creative and scientific approach to improving healthcare one disease at a time. Our clients include the largest reference labs, premiere academic medical centers, pharmaceutical firms, biotech companies, and others. Machaon Diagnostics is a 20-year old laboratory firm that is accredited by the College of American Pathologists (CAP), accredited by CLIA and multi-state licensed. We are experts in hemostasis, thrombosis, immunology, special chemistry, platelet physiology/function, molecular diagnostics, genetic assays and COVID-19. We maintain labs in Berkeley, CA and New Orleans, LA.

Company Overview:

Process Alliance is a leading engineering consultancy firm dedicated to delivering innovative solutions in engineering, automation, manufacturing services, and medical devices. With a commitment to being a better model of problem solving, we have been at the forefront of providing cutting-edge engineering services to clients across the life science industry. Our team of experts thrives on solving complex challenges and driving technological advancements to meet the evolving needs of our clients.

Overview:

We’re hiring an Associate Process Control / Automation Engineer to join a pharmaceutical manufacturing team. This full-time role is ideal for early-career engineers with 2+ years of experience in process automation, hands-on DeltaV Batch DCS work, and exposure to regulated manufacturing environments.

Key Responsibilities:

• Act as automation engineer for assigned unit operations, including DeltaV Batch DCS configuration and control module development
• Translate process engineering narratives into functional requirements and control logic
• Develop graphics in reference with process P&IDs and maintain communication with other process cell owners for alignment
• Interface with customer Process Engineering team and outsourced vendors
• Establish requirements for configuration, testing, and release in alignment with project schedule
• Review and provide oversight of vendor-provided software development
• Support Computer System Validation (CSV) documentation for assigned process cells
• Execute software application testing, including FAT/SAT activities

Qualifications:

• Bachelor’s degree in Chemical, Electrical, or Controls Engineering
• 2+ years of hands-on experience in process automation or process control in pharmaceutical or regulated manufacturing
• Experience with DeltaV Batch DCS required; familiarity with other DCS/PLC platforms (Honeywell, Rockwell PlantPAx) is a plus
• Knowledge of ISA-88 batch standards, GMP, and CSV principles
• Strong collaboration, communication, and documentation skills

About Our Culture:

At Process Alliance, we strive to be a better model for how problems are solved, and solutions are delivered. We believe in providing a supportive and inclusive work environment where employees can thrive both personally and professionally. Join our team and be part of a company that is shaping the future of engineering solutions.

Learn more about us:

Visit our website at to explore our projects, expertise, and the impact we make in the engineering and consultancy space.

Process Alliance is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences

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

Job Description: Compounding Pharmacist

Location: Houston, TX

Experience Level: 0–3 years

Employment Type: Full-time

About Us

We are a relatively new pharmaceutical startup based in Houston, Texas, focused on delivering high-quality compounded medications and personalized patient care. As a growing company, we offer exciting career development and advancement opportunities for driven professionals who want to make a meaningful impact from the ground up.

Responsibilities

• Prepare customized medications in accordance with prescriptions and compounding standards
• Ensure accuracy and compliance with all regulatory guidelines and safety protocols
• Communicate effectively with patients, healthcare providers, and team members
• Maintain meticulous records of formulations, ingredients, and inventory
• Collaborate with pharmacy technicians and support staff to ensure timely service
• Stay current with pharmaceutical trends and compounding techniques

Requirements

• Doctor of Pharmacy (PharmD) degree from an accredited institution
• Active pharmacist license in the state of Texas (or eligibility to obtain)
• 0–3 years of professional pharmacy experience
• Strong attention to detail and organizational skills
• Excellent verbal and written communication abilities
• Demonstrated responsibility, focus, and a hardworking attitude
• Compounding experience is a plus, but not mandatory

What We Offer

• Supportive team environment with mentorship opportunities
• Hands-on training in compounding practices
• Competitive salary and benefits package
• Career growth potential in a fast-growing startup pharmacy

JOB DESCRIPTION

Insight Global is seeking a highly skilled Rebate and Returns Analyst to assist commercial rebates, administrative fees, billbacks and other after sales expenses; ensure prompt payment to Wholesalers, Retailers, Distributors and Group Purchasing Organizations for one of our pharmaceutical organizations in the Elmwood Park, NJ area. This candidate will be preparing executive summary level reporting to the customer, field force and Contracts and Pricing management. This role requires close interaction with Credit and Collections, handling payment reconciliations as well as variance analysis against customer claims. Backfilling contract management as needed and working closely with A/R, A/P and GTN Team. Building and maintaining all customer incentive programs in revenue management system.

***Pharmaceutical experience is NOT required.

REQUIRED SKILLS AND EXPERIENCE

•Strong experience with Excel

•Comfortable going onsite 3 times per week in office in Elmwood Park, NJ

Industry: Pharmaceuticals

Title: Quality Assurance Associate II

Job ID: CAMB000111

Location: Cambridge MA (Hybrid)

Duration: 12 months contract (+Possibility of extension)

Duties

• Review of event documentation such as Batch records, Exceptions, and Regulatory filings
• Production record review and Product disposition for drug substance, drug product, device assembly and finished goods
• Support design development plan including design verification and DHF deliverables
• Build and maintain Product Specification Files (PSF) for Clients program

Skills

• Knowledge of relevant government regulations and agency rules for labeling (CFR & EudraLex Volume 4, Annex 13)
• Understanding of ICH, GLP, CGMP requirements, GXP regulations and current industry practices.
• Demonstrated teamwork, initiative, and problem-solving skills
• Ability to prioritize and work independently with minimal supervision
• Ability to accurately determine deadlines and ask for help if needed
• Detail oriented with solid problem solving acumen.
• Ability to work effectively in a team environment with great organization skills.
• Ability to independently analyze and reconcile moderate to complex issues.
• Must have demonstrated initiative and accountability in a fast paced environment.
• Excellent verbal and written communication and interpersonal skills.
• Proficient with computers and word processing software (i.e., Microsoft Office products)

Education

• Minimum, a BS degree in life sciences, engineering or related field
• Minimum of 5 years pharmaceutical quality assurance experience in a GMP manufacturing and supply chain environment
• To have been involved on a device development project before as QA
• Signed off on design development plan, completed design verification, approved DHF deliverables
• Good understanding of FDA and EMA regulations and guidelines
• Excellent organizational, communication, and interpersonal skills.
• Preferred Quality Drug Substance manufacture experience

Kelly® Science & Clinical is seeking a Quality Assurance Specialist for a temp-to-hire position at a premier pharma company in Rosenberg, TX. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay Rate:

$25-28/hour

Overview:

This client is a leading CDMO focused on providing services for the full drug product lifecycle. In this role, you will oversee inspections, sample collection, documentation, and material verification throughout all stages of pharmaceutical manufacturing and packaging, resolve quality issues collaboratively, and ensure compliance with GMP standards while communicating product release status and maintaining accurate records in a supportive team environment.

Schedule:

Monday-Friday, standard working hours

Responsibilities:

• Perform initial, in-process, and final inspections during manufacturing/packaging; resolve findings with Packaging or QA Management.
• Collect and label samples for release, validation, stability, and raw material testing; prepare and forward documentation to QC as needed.
• Monitor incoming materials in Quarantine; review receiving paperwork for accuracy and follow up on missing or incomplete CofAs.
• Inspect and approve/reject raw materials and components, including bottles, closures, cartons, and labels, verifying results with a second QA employee and updating system records accordingly.
• Prepare approval/rejection documentation, issue batch numbers, and assemble batch folders; coordinate with QA Manager on validation/stability designations.
• Issue batch documentation to production and review completed batch records for accuracy, resolving discrepancies with Production.
• Investigate material usage or yield discrepancies and assist in determining product disposition, including handling bright stock when applicable.
• Communicate product release status to Shipping and perform final pallet inspections to verify product name, lot, count, and order accuracy.
• Perform other related duties as required.

Qualifications:

• Bachelor’s degree Science or related field.
• 1+ years of experience in QA in pharmaceutical GMP environment.
• Strong working knowledge of GMP, SOPs, and DOPs.

Head of Analytical Development

Location: On-site near Union City, CA

Industry: Biopharmaceuticals / Biologics

A pioneering biopharmaceutical innovator in the Bay Area is expanding its R&D leadership and seeking a Head of Analytical Development. This role is vital to advancing the company’s innovative therapies pipeline, particularly within biologics, through scientific excellence, method innovation, and regulatory strategy. The company is preparing for pivotal product milestones and regulatory interactions, offering a high-impact role for a scientific leader ready to shape analytical development strategy and lead a cross-functional team.

Key Responsibilities:

• Provide strategic, scientific, and operational leadership across the analytical development function supporting biologics programs from early phase through commercialization.
• Lead development, optimization, validation, and transfer of analytical methods for drug substances, drug products, and non-compendial raw materials.
• Design and direct complex extended characterization studies to support regulatory filings and technical documentation.
• Collaborate cross-functionally with internal teams (Process Development, MSAT, Quality, Regulatory) and external partners (CROs, CDMOs, CTLs) to ensure analytical alignment across development stages.
• Guide laboratory operations and provide scientific mentorship to a team of scientists and technical leaders.
• Oversee stability studies of critical reagents and engineering/non-GMP batches to support formulation and manufacturing decisions.
• Act as the analytical SME in cross-functional teams and represent analytical function in CMC development and regulatory discussions.

Required Background:

• B.S. in biological sciences or related discipline with 8+ years (or M.S. with 6+ years) of progressive analytical development experience in the biotech or pharmaceutical industry.
• Proven experience leading scientific teams and mentoring scientists in an analytical development setting.
• Expertise in a broad range of analytical techniques such as SDS-PAGE, chromatography (HPLC/UPLC), CE-SDS, icIEF, ELISA, western blotting, and cell-based potency assays.
• Hands-on experience with advanced characterization techniques such as AUC, LC/MS, DLS, NMR, and circular dichroism.
• Demonstrated success in method development, validation, tech transfer, and authoring CMC documentation for regulatory submissions.
• Familiarity with DoE approaches and statistical tools like JMP, R, or Python.
• GxP experience and strong understanding of quality and regulatory standards.

Preferred Qualifications:

• Ph.D. in chemistry, biochemistry, pharmaceutical sciences, or related discipline.
• Experience in extended characterization (e.g., SEC-MALS, peptide mapping, disulfide mapping, PTM analysis).
• Background in neurotoxin or biologics development is a strong plus.
• Experience overseeing CRO/CDMO relationships and managing analytical-related quality documentation such as deviations, change controls, and investigations.

Why Join Us:

• Be at the forefront of biologic drug development in a high-growth company committed to improving patient outcomes.
• Influence CMC strategy and product development in a collaborative, science-first environment.
• Join a mission-driven culture that values innovation, scientific rigor, and operational excellence.
• Competitive compensation, bonus eligibility, comprehensive healthcare, flexible PTO, and professional development support.

About Blue Signal:

Blue Signal is an award-winning, executive search firm specializing in various specialties. Our recruiters have a proven track record of placing top-tier talent across industry verticals, with deep expertise in numerous professional services. Learn more at /46Gs4yS

Visual Inspection Associate

Duration: 6 month contract, potential for extension or conversion

Location: Pleasant Prairie, WI

Shift: 3rd shift 10PM-630AM

Position Overview:

The Operator – Visual Inspection will work at our client's Manufacturing site in Kenosha County WI, where parenteral products for domestic and international markets are manufactured and packaged. The primary purpose of this role is to safely inspect high-quality pharmaceutical products in accordance with site standards and current Good Manufacturing Practices (cGMP) within controlled facilities.

This position requires operation of various automated and semi-automated manufacturing equipment, as well as performance of manual inspections. The operator is responsible for ensuring product quality while demonstrating a strong commitment to safety, compliance, and operational excellence.

Responsibilities:

• Adhere to Parenteral Manufacturing safety policies and procedures and contribute to a safe work environment.

• Set up and operate non-aseptic manufacturing processes, including automated and semi-automated inspection equipment in controlled facilities.

• Follow standard operating procedures (SOPs), cGMP requirements, and safety policies and procedures.

• Accurately document process steps using appropriate batch documentation systems (paper and electronic).

• Participate in department meetings, team-building activities, and training programs.

• Provide input into department SOPs and training materials as needed.

• Maintain accountability for working safely and supporting all site and corporate health and safety goals.

Basic Requirements:

• Minimum education: High School Diploma or GED

• Must pass a post-offer physical examination

• Must pass an eye exam and not be color blind

• Ability to wear required safety equipment (safety glasses, safety shoes, protective gloves, etc.)

• Ability to work within a shift-based schedule

• Willingness to work overtime, weekends, and off-shifts as required

Additional Skills / Preferences:

• Experience working in a GMP-regulated environment

• Ability to troubleshoot basic production issues and effectively use tools

• Experience with PMX, MasterControl, Flow-stream, or other electronic batch documentation systems

• Previous pharmaceutical manufacturing experience

• Experience with manual, automated, and semi-automated inspection processes

• Strong attention to detail when performing manufacturing tasks and documenting production activities on paper and computer-based systems

• Basic math skills, including evaluation and interpretation of production data

• Basic computer skills, including use of HMIs and other computer terminals to monitor equipment status and document production activities

• Excellent documentation skills

• Proven teamwork skills and ability to work closely with operations teams during line setup, operation, and changeovers

Additional Information:

• Ability to work overtime as required

• Ability to wear required safety equipment (glasses, shoes, gloves, etc.)

• Primary work location: Kenosha County, Wisconsin

• Ability to travel up to approximately 10%

This job description is intended to provide a general overview of the job requirements at the time it was prepared. Job responsibilities may change over time and may include additional duties not specifically described. For GMP purposes, the job description should be updated for significant changes. Employees should consult their supervisor regarding actual job responsibilities and related duties.