Pai Pharma Jobs in Usa

Pay $37-$39 per hour DOE

Seeking a tactical, detail-oriented Quality professional to support external-facing quality records related to raw material suppliers. The ideal candidate will have 3-5 years of hands-on experience managing deviations, change controls, and CAPAs using systems like TrackWise or Veeva. A strong grasp of root cause analysis and investigation review is essential. Candidates should have a background in biotech or medical device industries, with the ability to operate in a fast-paced, remote environment. Bachelors Degree is best but associate-degree holders with deep experience (10+ years) will be considered. Overqualified individuals (e.g., former directors or PhDs) and those without relevant quality records experience should not be submitted.

Quality records experience working with suppliers would be a home run candidate.

Basic project management skills required.

The Specialist Manufacturing is expected to own and execute under minor supervision all the processes related to deviations (minor and majors), Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR /EN), and Change Control quality records. This Specialist Manufacturing will act as the External Supply representative across functional teams and drive closure of quality records in a timely manner. The Specialist Manufacturing, External Supply owns and manages quality records originating from manufacturing sites across the network. In addition, this role will be the main External Supply quality record owner point of contact for New Albany, OH site.

Responsibilities:

- Address and close quality records (Deviations, Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR /EN), and Change Control) under the company's quality management system procedures and ensures compliance with regulatory agency requirements.

- Monitors and investigate deviations owned by External Supply and implements corrective / preventive actions. Partner cross-functionally across the site to ensure maturity and execution of robust Deviations / CAPA process

- Build and present quality records summaries for Senior Management review. Provide timely and comprehensive process and status updates to senior management

- Support New Albany, OH site as the external supply quality record owner main point of contact and collaborates with the site and technical teams to evaluate observed supplier related defects.

POSITION SUMMARY: The Sr. EHS Specialist is responsible for complex technical work within a range of EHS disciplines.The Sr. EHS Specialist will assist and support to the Associate Director of EHS in the development, implementation, and monitoring of the site’s EHS programs designed to protect the health, safety, and well-being of all Ash Stevens employees, visitors, contractors, the Community, and the local environment as well as compliance with all relevant EHS regulations and best industry practices.

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, MIOSHA, MI DEQ, and related EHS procedures, policies, and practices.
• Consistent support of Ash Stevens’ mission and values.
• Identify and protect the original technical information as part of the company property.

KEY ACCOUNTABILTIES:

• With limited supervision, assist and support the Associate Director of EHS with the development, implementation, and continuous improvement of all EHS management systems and programs.
• Support business plan KRAs/goals and develop and monitor to ensure goals are achieved.
• Develop implement, document, and periodically review Company training programs related to EHS to protect workers and satisfy regulatory and site requirements.
• Develop, review, approve and implement SOPs, Work Instructions, and all other EHS documents.
• Support site management with incident investigations, root cause analyses, and assignment & tracking of CAPAs as needed.
• Partner closely with internal cross-functional stakeholders to communicate, secure support, and inform the facility of EHS compliance risks and gain alignment on EHS initiatives and priorities.
• Ensure that the site complies with applicable EHS regulations and Company requirements, guidelines, and policies and takes the necessary steps to prevent non-conformances.
• Ensure that all EHS reporting, both internally and externally, is conducted timely and accurately.
• Assist with safety evaluations and risk assessments (JHA, PHAs, HAZOPs, FMEAs, PSSRs, etc.) of new products, processes, facilities, and equipment and recommend CAPAs to improve safety performance.
• Provide technical support for EHS programs (LOTOTO, Hazcom, Respiratory Protection, Chemical Hygiene, etc.)
• Assist with the development of annual EHS KRAs, goals, plans, objectives, and budget as directed by the AD.
• Complete requisite environmental reporting (Tier 2, biennial hazardous waste, air emissions, TRI, and stormwater) as directed by AD.
• Reporting injury/illness data electronically to OSHA & generating and posting requisite site reports
• Assigning and managing EHS education and training using MasterControl software system.
• Conducing new hire orientation (NHO) safety training and education as needed.
• Maintain and control site SDSs for RMs, SMs, IPs, and FPs per Hazcom Standards.
• Conduct qualitative/quantitative exposure assessments for hazardous materials and HPAPIs.
• Assessing site compliance with corporate policies/guidelines and federal, state, and local regulations through periodic workplace audits and walkthroughs (Gemba walks).
• Responsible for guiding Site Safety Committee (SSC) activities and initiatives.
• Work closely with Facilities, Engineering, Manufacturing, and Laboratory teams to ensure contractors and subcontractors work in compliance with all site EHS requirements (Safe Work Permits, PRCS entries, LOTOTO, hot work, etc.)

EDUCATION/EXPERIENCE:

• Bachelor’s degree in EHS, Engineering, Chemistry, Industrial Hygiene, or similar degree required.
• Master’s degree in EHS or related field preferred.
• Minimum of 5 years of EHS experience in a pharmaceutical manufacturing environment preferred
• EHS Certifications are a plus (CSP, CIH, QEP, CHMM)
• Sustainability & ESG experience are a plus.
• SDS authoring
• HPAPI containment and isolation equipment and practices.

JOB COMPETENCIES

• Excellent organizational and planning skills.
• Strong leadership and ability to influence all levels of employees.
• Strong problem solving/troubleshooting skills.
• Strong auditing and risk-assessment skills.
• Ability to self-lead work tasks to completion.
• Proficient in MS Office (Word, Visio, PowerPoint, & Excel), Emission Master, SAP, and Smartsheet.
• Strong written, verbal, and interpersonal communication skills.
• Excellent presentation and adult learning skills.
• Ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.
• Self-motivated and detail oriented.

Scientist II

Location: Worcester, MA

Work Arrangement: 100% onsite

Contract Duration: 12 months

Overview

We are seeking a highly motivated and talented Scientist II to join our In Vivo Antibody Discovery and Molecular Core team in Worcester, MA. This is a newly created role driven by increased workload, supporting a team of six scientists.

This R&D-focused position centers on high-throughput next generation sequencing (NGS), primarily working with human cells. The role involves upstream processing, including working with primary cells (p cells), DNA extraction, sequencing preparation, and data analysis, with results shared with downstream scientists.

Key Responsibilities

Experimental Design & Execution

• Independently design, execute, and interpret experiments utilizing microfluidics to amplify heavy and light chain genes and generate DNA libraries for deep sequencing of single B cells captured in droplet emulsions
• Understand project objectives and adapt experimental plans as needed while meeting timelines

Molecular Techniques

• Perform RNA isolation and DNA purification
• Amplify antibody heavy- and light-chain variable regions from single cells or lysates
• Prepare and submit DNA libraries for next generation sequencing (MiSeq/MiSeq i100)

Bioinformatics & Data Analysis

• Conduct sequencing data analysis of cells
• Perform in silico antibody genetic analysis and data visualization using standard and custom bioinformatics tools
• Utilize coding/data analysis at a basic to intermediate level (preferred)

Collaboration

• Present and discuss experimental findings with cross-functional teams
• Support multiple programs across the in vivo antibody discovery portfolio
• Work both independently and collaboratively while managing multiple projects

Qualifications

• 3–5 years of experience
• Hands-on experience with DNA sequencing (Illumina) – required
• Microfluidic experience – required
• Experience working with next generation sequencing (NGS)
• Molecular biology expertise
• DNA/RNA purification experience
• Primary cell (p cell) experience
• Data analysis background – preferred
• Basic to intermediate coding/data experience – preferred

Education

• Bachelor’s or Master’s degree required
• PhD is overqualified (OQ)

Required Skills & Experience

• Master’s degree in biology, immunology, cell/molecular biology, or related discipline with experience in single B cell sequencing research and 2+ years of relevant experience (MS)
• Demonstrated hands-on expertise in droplet microfluidics of single B cells and next generation sequencing of IgG variable heavy and light chains
• Familiarity with next generation sequencing platforms (Illumina MiSeq and MiSeq i100) and B cell genetic data analysis software/databases (FLASH, IgBlast, Usearch, IMGT)
• Experience in reverse transcription, RNA/DNA isolation and purification, overlap extension PCR, primer design, cDNA library generation, and gel electrophoresis
• Protein and cell detection methods experience (ELISA and/or FACS) – preferred

Additional Details

• Reason for Need: New role due to increased workload
• Team Size: 6

Summarized Purpose:

Provides high quality customer service to client customers including consumers, health care professionals (HCPs), and client personnel. Documents interactions according to internal and client guidelines. Identifies adverse events (AEs) and product complaints (PCs). Processes fulfillment (e.g., mail, fax, e-mail) and performs administrative responsibilities as needed.

Essential Functions:

• Provides high quality customer service to client customers including consumers, HCPs, and client personnel.

• Documents interactions according to PPD and client guidelines. Identifies AEs events and PCs.

• Maintains knowledge of policies and procedures including client products, SOPs, protocols, GCPs, and all applicable regulatory requirements.

• Processes medical information request (e.g., fulfillment) via e-mail; fax and regular mail.

• Performs line checks and system verifications, and generate reports.

• Performs other duties as assigned.

Education and Experience:

•High School diploma / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years) or equivalent combination of education, training, & experience

• In some cases a second language may be required

• Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities:

• Excellent organizational skills

• Strong attention to detail

• Ability to handle multiple tasks

• Effective verbal and written communication skills

• Excellent problem solving skills

• Excellent language skills (comprehension, speaking, reading and writing); Fluency skills in a second language may be required

• Excellent computer and keyboarding skills

• Time management skills

• Excellent interpersonal skills

• Ability to work in a team environment and/or independently as needed

• Demonstrated confidence and initiative

• Flexibility

Pay $26 - $28 per hour DOE

Top 3 Must Haves:

1. Use Waters Empower system (or other LC platform) to perform liquid chromatography analysis, experience in large molecules analysis is a plus.

2. Experience with operation, maintenance, and troubleshooting of chromatographic and spectroscopic laboratory equipment.

3. Perform the Karl Fisher Titration for water content analysis.

This individual will support chemists by analyzing samples using various chromatographic techniques, optimizing analytical methods for accuracy and repeatability, and troubleshooting instrumentation as needed. The ideal candidate should demonstrate strong problem-solving skills, be adept at overcoming complex analytical challenges, and take a proactive approach to supporting and improving laboratory operations.

• Hands on execution of routine sample preparation and analysis for in process, lot release, and stability samples using chromatographic and spectroscopic techniques for synthetic small molecules and/or oligonucleotides.
• Organize and document analytical data under Good Documentation Practice using an electronic laboratory notebook system.
• Provide and present results to support process development.

• Operation of packaging equipment (e.g.: labelers, pick and place, heat tunnel, vision systems, forklift, etc.)
• Inspect product accurately and efficiently to meet quality guidelines.
• Perform equipment change-over, set-up.
• Responsible for initial troubleshooting for packaging equipment issues (e.g. Labelers, Pick and place, heat tunnel, etc.)
• Ensure that proper cGMP documentation is follow for completeness and adherence to our procedures and in a timely manner.
• Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures.
• Preparation of QA Line clearances (e.g. Small volume line).
• Maintains a safe, clean and organized work environment.
• Maintains facilities and equipment as required by Standard Operating Procedures.
• Cross-training in other areas within the department as require to meet business needs.
• Other duties as assigned by the Shift Line Leader or Supervisor

Office Assistant

Location: New Providence, New Jersey

Employment Type: Contractor to Permanent (3–6 month trial period)

Work Schedule: 4–5 days per week in office, with optional remote work on Fridays

About the Role

We are seeking a proactive and organized Office Assistant to support daily office operations and provide administrative support to leadership. This role combines office management, employee engagement, and executive assistance, requiring someone who thrives in a small, dynamic company environment. The ideal candidate is flexible, solution-oriented, and enjoys creating a positive and collaborative work atmosphere.

Key Responsibilities

Office Support

• Support daily office functions and create a welcoming environment for employees and visitors.
• Serve as the main point of contact at reception: greet guests, answer office questions, manage mail, and handle shipments.
• Be prepared to handle regulatory visits appropriately.
• Assist employees with planning office meetings, including site coordination and catering orders.
• Manage office vendors, including equipment maintenance and supply orders.
• Coordinate with building management on issues like temperature, cleaning, and other facilities needs.
• Create new hire badges, conduct office tours, and review office procedures.
• Assist in organizing company-wide events, executive meetings, off-sites, office lunches, team activities, and holiday parties.
• Foster a positive and collaborative office culture.
• Support ad-hoc projects and tasks as needed.

Administrative Support

• Provide proactive administrative support to leadership, including calendar management and resolving scheduling conflicts.
• Coordinate domestic and international travel; assist with expense reporting.
• Schedule recurring meetings, prepare agendas, and distribute meeting materials.
• Manage purchase orders, process invoices, and assist with financial administration tasks.
• Support recruitment efforts by scheduling interviews, coordinating candidate travel, and providing onsite support.
• Prioritize competing tasks and act proactively to address organizational needs.
• Serve as a versatile team member, contributing to special projects and covering gaps as they arise.
• Anticipate problems, take initiative, and provide solutions before issues escalate.
• Collaborate with other office admin team members to maintain an efficient and positive workplace.

Requirements

Education & Experience

• Bachelor’s degree preferred.
• 5+ years of experience in office coordination/management.
• 2+ years of experience in an administrative support role.
• Experience in pharmaceutical or biotech industries preferred but not required.

Skills & Attributes

• Positive, can-do attitude with a willingness to help others.
• Self-starter with a “roll up your sleeves” mentality.
• Strong written and verbal communication skills.
• Proficient in Microsoft Office, Teams, and advanced Outlook calendar management.
• Excellent interpersonal skills with the ability to build relationships across the organization.
• Highly organized with strong multitasking and prioritization abilities.
• Ability to work independently and collaboratively.
• Trustworthy and discreet with confidential information.
• Flexible and adaptable to handle ad-hoc tasks as needed.
• Able to lift boxes and office supplies over 30 lbs

Main Purpose:

US site security officers assigned to site uniform patrol or static posts are responsible for proactive safe guarding of site properties and for the proper handling of calls for security services. Security Officers may serve as liaison with police or other law enforcement agencies on mutual problems, respond to fire alarms and assist in the evacuation of employees in emergency situations. Security officers will prepare clear and accurate computer generated reports of incidents and other activities and ensure protection of employees, physical assets, intellectual properties and information assets.

Scope (global, regional, or local): Local

Key Working Relations (Internal/External):

1. Internal Employees, contractors, visitors, and guests across all business units

2. External local law enforcement, emergency services personnel, utility personnel, and security support vendors

3. Collaborate with and train site employees and security personnel while recommending security implementation upgrades and policies

4. Develop reporting mechanisms while strategically collaborating with internal stakeholders to ensure security policies/procedures are implemented and incidents are reported appropriately and timely to Corporate Security Management

7. Participate or lead programs, trainings, workshops, security know how campaigns and the implementation of directives that enhance the personal security of employees within their workplace

Key Tasks:

1. Performing mobile patrol of site within geography of responsibility on roadways and parking lots

2. Protecting sites from trespassers or illegal entry

3. Protecting against damage or theft of company property

4. Investigating and respond to calls for service

5. Providing emergency services and rescue, CPR and first aid during sudden illnesses or injury

6. Responding to intrusion and equipment alarms

7. Conduct initial investigations of accidents, or crimes against company property or employees

8. Fostering an environment of trust and confidence through exemplary integrity and professionalism

9. Preparing appropriate report documentation

10. Ability to think independently, react to changing conditions and be able to make sound decisions based upon existing circumstances

11. In the event of an emergency, maintaining order and the safety of employees and visitors

Qualification & Competencies:

1. Bachelor's degree is preferred; High School diploma or equivalent required

2. Law enforcement, military and/or corporate security experience is required

3. The ability to work autonomously and with limited supervision

4. Excellent interpersonal and communication skills

5. The ability to prepare clear, succinct, accurate, professional and timely written communications

6. The ability to maintain all certifications and training as required by jurisdiction of authority and possess a valid driver's license

7. The ability to obtain and maintain the State of Hawaii "Guard Card" according to the State of Hawaii HRS 463 10.5

8. Experienced in basic computer skills

9. Able to work rotating shifts and available for overtime and weekend shifts

10. The ability to work in excess of the normal eight hour day when necessary

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