CrawlJobs Logo

Associate Engineer, Drug Product Development

pipercompanies.com Logo

Piper Companies

Location Icon

Location:
United States , Branchburg

Category Icon

Job Type Icon

Contract Type:
Employment contract

Salary Icon

Salary:

75000.00 - 80000.00 USD / Year

Job Description:

Piper Companies is seeking an Associate Engineer to support Drug Product Development for a leading biotechnology company developing next-generation allogeneic cell therapies for oncology. This is an onsite position in Branchburg, NJ and a long term contract assignment with potential for conversion. Weekend flexibility also highly preferred.

Job Responsibility:

  • Develop and implement manufacturing processes capable of supplying clinical trials with material complying to product quality targets, current cGMP, and regulatory requirements
  • Support the delivery of engineered immune cells to internal and external groups
  • Identify novel solutions to address key technical challenges required for manufacturing platform success, such as cryo-preservation and cell culture media optimization
  • Contribute to experimental strategy toward at-scale cell differentiation, expansion, formulation, and in-process testing
  • Collaborate with internal partners (Process Development, Analytical Development) to integrate stem cell process technology
  • Maintain laboratory procedures, systems and electronic notebooks, to ensure documentation of experimental activities

Requirements:

  • BS/MS degree in cell biology, biochemistry, biochemical engineering, or related field, ideally with 2-6 years of relevant industry experience
  • Functional experience in mammalian cell culture process development, including molecular biology, aseptic techniques, and cryo-preservation
  • Experience with mammalian cell culture and media optimization
  • Understanding of cell biology/physiology and/or engineering fundamentals
  • Understanding of bioprocess characterization and validation concepts, cGMP, and GLP

Nice to have:

  • Experience with Rotea, LOVO, Xuri, and other cell culture unit operations is preferred
  • Experience with induced pluripotent stem cells (iPSC) is desirable
What we offer:

Medical, Dental, Vision, Sick Leave as required by law, and PTO

Additional Information:

Job Posted:
January 06, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Associate Engineer, Drug Product Development

Associate Director, Drug Product Manufacturing and Development (Oral)

The Associate Director, Drug Product will support drug product activities with e...
Location
Location
United States , San Diego
Salary
Salary:
160000.00 - 200000.00 USD / Year
kailera.com Logo
Kailera Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 10+ years of experience in the pharmaceutical industry with a proven track record of technical expertise in unit operations common to solid oral dosage form (e.g., dry granulation, compression and film-coating)
  • Extensive experience with management and oversight of activities at CDMO’s
  • Strong troubleshooting skills with the ability to quickly provide input in a fast-paced environment
  • Strong working knowledge of Excel, Word, PowerPoint
  • Experience drafting CMC documents for regulatory filings
  • Experience using quality systems such as Veeva to author and approve documents
  • Excellent verbal, written and interpersonal skills
  • Innovative team-player capable of working cross-functionally to achieve program goals
  • Ability to travel up to 20% (domestic and international)
  • Bachelors Degree in Engineering, Pharmaceutical Sciences, Life Sciences or closely related field
Job Responsibility
Job Responsibility
  • Contribute to the selection, engagement, and management of CDMO’s, including assessment of capabilities, drafting requests for proposals, and providing recommendations based on selection criteria
  • Coordinate technology transfer, formulation and process development, optimization, scale-up and manufacturing of clinical supplies, acting as Kailera’s person-in-plant for activities critical to program success
  • Collaborate closely with internal cross-functional teams, including Drug Substance, Analytical Development, Supply Chain, Clinical, Quality Assurance, and Regulatory Affairs to ensure seamless progression of projects
  • Review master batch records and executed batch records to ensure product quality
  • Manage cGMP change controls and manufacturing deviations as necessary, working closely with Kailera’s quality group
  • Lead initiatives to enhance manufacturing efficiency, reduce costs and improve product quality through experimental design with a focus on commercial preparedness
  • Author, review, and update CMC specific documents to support worldwide regulatory submissions (i.e., IND, IMPD and NDA)
What we offer
What we offer
  • Comprehensive health benefits and tax-advantaged savings accounts
  • Flexible time off, 13 paid holidays, and a companywide year-end shutdown
  • Monthly wellness stipend
  • Generous 401(k) match
  • Disability and life insurance
  • Fulltime
Read More
Arrow Right

Specialist Manufacturing - Drug Product Operations

Join Amgen’s Mission of Serving Patients. At Amgen, our mission—to serve patient...
Location
Location
United States , Thousand Oaks
Salary
Salary:
114990.00 - 139433.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree
  • Master’s degree and 2 years of Manufacturing support experience
  • Bachelor’s degree and 4 years of Manufacturing support experience
  • Associate’s degree and 8 years of Manufacturing support experience
  • High school diploma / GED and 10 years of Manufacturing support experience
Job Responsibility
Job Responsibility
  • Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs)
  • Serve as document author, owner, reviewer, or data verifier
  • Maintain documentation to accurately reflect operational practices and regulatory requirements
  • Support implementation of new processes, equipment, and major initiatives within Drug Product operations
  • Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness
  • Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations
  • Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement
  • Develop and implement data-driven solutions to improve yield, reliability, and compliance
  • Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire
  • Support timely investigation and resolution of manufacturing deviations
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
  • Fulltime
Read More
Arrow Right

Sr. Associate Manufacturing Production Process Owner

In this vital role you will partner with cross-functional teams—including Engine...
Location
Location
United States , Thousand Oaks
Salary
Salary:
92002.00 - 108605.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school/GED + 4 years Manufacturing support experience
  • Associate’s + 2 years Manufacturing support experience
  • Bachelor’s + 6 months Manufacturing support experience
  • Master's
  • Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, or related field
  • Experience in aseptic Drug Product or biologics manufacturing
  • Knowledge of process validation, deviation management, and change control
  • Strong analytical and problem-solving skills with experience using data visualization tools (Spotfire, JMP, Excel)
  • Excellent written and verbal communication skills and ability to collaborate across functions
Job Responsibility
Job Responsibility
  • Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs)
  • Serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards
  • Maintain documentation to accurately reflect operational practices and regulatory requirements
  • Support implementation of new processes, equipment, and major initiatives within Drug Product operations
  • Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness
  • Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations
  • Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement
  • Develop and implement data-driven solutions to improve yield, reliability, and compliance
  • Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire, ensuring configuration alignment with process design and GMP requirements
  • Support timely investigation and resolution of manufacturing deviations
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
  • Fulltime
Read More
Arrow Right

Senior Engineer- Process Development/NPI

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...
Location
Location
United States , New Albany
Salary
Salary:
123098.00 - 149145.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree
  • Master’s degree and 2 years of Process Development, Engineering, or NPI experience
  • Bachelor’s degree and 4 years of Process Development, Engineering, or NPI experience
  • Associate’s degree and 8 years of Process Development, Engineering, or NPI experience
  • High school diploma / GED and 10 years of Process Development, Engineering, or NPI experience
Job Responsibility
Job Responsibility
  • Serve as project manager and technical expert for Final Drug Product New Process Introductions (NPI) into Amgen Ohio
  • Lead multi-functional NPI teams
  • Lead the NPI’s for necessary process, facility, equipment, materials, and training modifications
  • Development of project execution plans
  • Ensuring process requirements are effectively transferred into manufacturing
  • Coordination/execution of NPI activities
  • Function as the NPI project manager and is accountable for NPI scope, schedule, resources, and risk management
  • Engage with network partners to develop process and technology strategies
  • Collaborate with Combination Product Operations, Quality, and Regulatory partners to manage change control processes
  • Support generation, revision, review, execution, and approval of relevant technical documents
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models, including remote and hybrid work arrangements, where possible
  • Fulltime
Read More
Arrow Right

Senior Manufacturing Associate – Single Use Systems (SUS)

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...
Location
Location
United States , Holly Springs
Salary
Salary:
92002.00 - 108605.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School/GED and 4 years of manufacturing or operations work experience
  • Associate’s Degree and 2 years of manufacturing or operations work experience
  • Bachelor’s Degree and 6 months of manufacturing or operations work experience
  • Master’s Degree
  • Experience with and understanding of Single-Use Systems
  • Experience in Drug substance GMP technical support roles, GMP manufacturing, Engineering, Process Development, or equivalent
  • Technical knowledge of drug substance processing and broad understanding of related disciplinary areas
  • Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
  • Ability to coach, mentor and/or cross train colleagues within core technical area
  • Team player - Ability to support process owner team by reprioritizing or readjusting projects, tasks, or responsibilities
Job Responsibility
Job Responsibility
  • Support New Product introduction and projects through SUS mapping/drawing
  • Maintain and edit SUS Standard Operating Procedures (SOP)
  • Support manufacturing and quality through the SUS defect/leak triage process – perform troubleshooting on the floor, initiate investigations and bring leaks and defects to triage meetings
  • Initiate Event Notification (EN)/Supplier Investigation/Corrective Action (SICAR) records and follow process to conclusion, including collaborating with vendors on investigation
  • Maintain up-to-date EN/SICAR/Early Engagement (EE=new item) trackers and manage or lead small to medium projects
  • Provide input for ANC representative to SUS network for improvements and troubleshooting
  • Support Vendor Change Notification assessments
  • Understand single-use material capabilities and user requirements for new technologies through interaction with end users
  • Collaborate with Continuous Improvement (CI) leads to help SUS improvement projects and provide/lead use cases for continuous improvement projects. For example, improvements around tubing management, material kitting and flow
What we offer
What we offer
  • competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
  • Fulltime
Read More
Arrow Right

Sr Quality Engineer

In this vital role you will act as the Quality Engineering representative on mul...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree
  • Master’s degree and 4 to 6 years of Quality experience
  • Bachelor’s degree and 6 to 8 years of Quality experience
  • Diploma and 10 to 12 years of Quality experience
  • 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry (device experience a plus)
  • Bachelor’s Degree in a Science Field
  • Ability to oversee multiple medium complexity projects simultaneously
  • Working knowledge of quality engineering and/or mechanical engineering
  • Familiar with final products including applicable guidance, regulations and standards (e.g., MDR, ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211)
  • Prior experience working as part of a combination product launch team
Job Responsibility
Job Responsibility
  • Act as the Quality Engineering representative on multi-functional teams
  • Employ quality principles and company’s procedures including but not limited to the areas of device design control, Change Control and NC/CAPA, Risk Management, Human Factors Engineering
  • Ensure development and lifecycle management of final product align with dynamic global regulations and standards
  • Provide Quality technical expertise, Quality oversight, and serve as a single point of Quality contact for combination and non-combination products associated with final product activities
  • Ensure program alignment and proper linkages within the Design and Development Plans, Risk Management Documentation, and Control Plans
  • Provide oversight and review of Human Factors Engineering (HFE) Protocols and Reports, as well as onboarding and auditing HFE suppliers related to life cycle management of commercial programs
  • Train and educate key functional partners and management on combination product requirements, standards and regulations
  • Contribute to content and review of regulatory submissions and RTQs, and support audits and inspections for associated projects related to life cycle management of final product programs
  • Plan and lead continuous improvements to the quality processes related to devices, combination product, assembly, labeling and packaging
  • Provide independent design review for other programs
What we offer
What we offer
  • Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
Read More
Arrow Right

Specialist Manufacturing: NPI, Process Owner

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...
Location
Location
United States , Holly Springs
Salary
Salary:
114990.00 - 139433.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma / GED & 10 years of biotechnology operations experience
  • Associate’s degree & 8 years of biotechnology operations experience
  • Bachelor’s degree and 4 years of biotechnology operations experience
  • Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience
  • Doctorate degree
  • Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
  • Excellent cross-functional project management, meeting facilitation, and technical writing skills
  • Experience in Downstream GMP manufacturing operations
  • Strong technical knowledge of drug substance processing (harvest, chromatography, filtration, buffer preparation) and a broad understanding of related disciplinary areas in bioprocessing
  • Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.
Job Responsibility
Job Responsibility
  • Communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups
  • Ensure new products are successfully introduced into ANC’s biologics manufacturing facility and ownership of downstream unit operations
  • Host cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some downstream process unit operations
  • New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet)
  • Downstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes
  • Support Manufacturing in troubleshooting, problem solving and RCAs
  • Support CAPA development to prevent error recurrence
  • Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion
  • Responds to regulatory questions and/or audit findings
  • Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date
What we offer
What we offer
  • Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
  • Fulltime
Read More
Arrow Right

Specialist Manufacturing: NPI, Upstream Process Owner

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...
Location
Location
United States , Holly Springs
Salary
Salary:
114990.00 - 139433.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma / GED & 10 years of biotechnology operations experience
  • Associate’s degree & 8 years of biotechnology operations experience
  • Bachelor’s degree and 4 years of biotechnology operations experience
  • Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience
  • Doctorate degree
  • Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
  • Excellent cross-functional project management, meeting facilitation, and technical writing skills
  • Experience in Upstream GMP manufacturing operations
  • Strong technical knowledge of Upstream drug substance processing (media preparation, cell culture, harvest) and a broad understanding of related disciplinary areas in bioprocessing
  • Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.
Job Responsibility
Job Responsibility
  • Communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups
  • Ensure new products are successfully introduced into ANC’s biologics manufacturing facility and ownership of upstream unit operations
  • Host cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some upstream process unit operations
  • New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet)
  • Upstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes
  • Support Manufacturing in troubleshooting, problem solving and RCAs
  • Support CAPA development to prevent error recurrence
  • Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion
  • Responds to regulatory questions and/or audit findings
  • Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date
What we offer
What we offer
  • Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
  • Fulltime
Read More
Arrow Right