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Biologics Manufacturing Jobs (NOW HIRING)

Catalyx

Automation SME

Gaithersburg, MD ยท On-site

Responsibilities ยท Provide technical leadership for automation systems supporting biologics manufacturing, including upstream, downstream, buffer/media preparation, and clean utility systems. ยท ...

Syner-G

Staff Process Engineer

Tustin, CA ยท On-site

Syner-G is seeking a highly experienced Staff Process Engineer / MSAT Technology Transfer Lead with 10-15+ years of biologics manufacturing experience to provide technical and program leadership for ...

Abzena Inc.

MSAT Manager - Shift B

San Diego, CA ยท On-site

$160K - $180K/yr

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward ...

Kinetic Personnel Group

Downstream Process

Tustin, CA ยท On-site

Biopharmaceutical CDMO / Biologics Manufacturing Location: Irvine, CA (Onsite) Employment Type: Full-Time Schedule: Mondayรขย€ย“Friday | Standard Business Hours (Flexibility for manufacturing support ...

UCB

US Bio Manuf. Drug Substance Expert

Atlanta, GA ยท On-site

$148K - $195K/yr

About the role UCB is investing in a new state-of-the-art biologics manufacturing facility in the United States to support our growing number of patients. As a Senior Biomanufacturing Process Expert ...

Eurofins

Manufacturing Tech

Saint Louis, MO ยท On-site

Some knowledge of biologics manufacturing unit operations. * General chemistry background (e.g. understanding of Henderson-Hasselbalch equations, conductivity, and osmolality). * Knowledge of ...

UCB

US Bio Manuf. Drug Substance Expert

Atlanta, GA ยท Hybrid

$148K - $195K/yr

About the role UCB is investing in a new state-of-the-art biologics manufacturing facility in the United States to support our growing number of patients. As a Senior Biomanufacturing Process Expert ...

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Biologics Manufacturing information

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How much do biologics manufacturing jobs pay per hour?

As of Aug 17, 2026, the average hourly pay for biologics manufacturing in the United States is $24.95, according to ZipRecruiter salary data. Most workers in this role earn between $20.19 and $28.85 per hour, depending on experience, location, and employer.

How to become a biologics manufacturing specialist?

To become a biologics manufacturing specialist, candidates typically need a bachelor's degree in biology, biochemistry, or a related field. Gaining experience through internships or entry-level roles in pharmaceutical or biotech manufacturing, along with knowledge of Good Manufacturing Practices (GMP) and familiarity with bioprocessing tools, is essential. Certifications such as the Certified Pharmaceutical GMP Professional can also enhance job prospects.

What are some common challenges faced by professionals in biologics manufacturing, and how can they be addressed?

Professionals in biologics manufacturing often encounter challenges such as maintaining strict compliance with regulatory standards, ensuring consistent product quality, and troubleshooting equipment or process deviations. Addressing these challenges requires a strong understanding of Good Manufacturing Practices (GMP), attention to detail, and effective communication within cross-functional teams. Continuous training, proactive problem-solving, and collaboration with quality assurance specialists can help ensure smooth operations and career progression in this dynamic field.

What is the difference between Biologics Manufacturing vs Bioprocess Technician?

AspectBiologics ManufacturingBioprocess Technician
CredentialsTypically requires a degree in biology, biochemistry, or related field; certifications like cGMP training are commonSimilar credentials; often holds a degree in life sciences and cGMP or manufacturing certifications
Work EnvironmentManufacturing facilities, cleanrooms, production linesLaboratory and production environments, operating bioreactors and equipment
Industry UsageUsed across biologics production companies, biotech firms, pharmaceutical manufacturersCommonly employed in biologics manufacturing plants, biotech labs, and GMP facilities

Biologics Manufacturing involves overseeing the entire production process of biologic drugs, including process development and quality control. Bioprocess Technicians focus on operating equipment, monitoring processes, and ensuring compliance during manufacturing. Both roles require similar credentials and work in comparable environments, but biologics manufacturing has a broader scope including process design and validation.

What is biologics manufacturing?

Biologics manufacturing refers to the process of producing complex medicines derived from living organisms, such as proteins, antibodies, or vaccines. Unlike traditional pharmaceuticals, biologics are typically made using cells cultured in controlled environments, making the process more intricate and tightly regulated. This field involves steps like cell culture, purification, formulation, and quality control to ensure the safety and effectiveness of the final product. Biologics manufacturing is essential for creating treatments for a wide range of diseases, including cancer, autoimmune disorders, and infectious diseases.

What are the key skills and qualifications needed to thrive in biologics manufacturing, and why are they important?

To thrive in Biologics Manufacturing, you need a solid background in biology, chemistry, or biotechnology, often supported by a relevant degree or industry certification. Familiarity with Good Manufacturing Practices (GMP), bioprocessing equipment, and data management systems like LIMS is essential. Attention to detail, problem-solving skills, and the ability to work collaboratively in a team environment help individuals excel in this field. These competencies ensure the safe, efficient, and compliant production of biologic products critical for patient health and regulatory approval.
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The top searched job categories for Biologics Manufacturing jobs are:

Biologics Manufacturing jobs near you
Infographic showing various Biologics Manufacturing job openings in the United States as of August 2026, with employment types broken down into 89% Full Time, 4% Part Time, 4% Contract, and 3% Nights. Highlights an 95% Physical, 2% Hybrid, and 3% Remote job distribution, with an average salary of $51,890 per year, or $24.9 per hour.

Staff Product Transfer Project Engineer - Bioprocessing

WilsonCTS

Franklin, TN โ€ข Hybrid

$60 - $64/hr

Full-time

Posted 16 days ago

Job description

Job Title: Staff Product Transfer Project Engineer - Bioprocessing
Employment Type: Contract (18-months)
Work Location: Franklin, Tennessee
Work Arrangement: Hybrid (3 days - onsite)
Pay Rate: $60-$64 per hour
Travel: Up to 25% domestic and international travel, depending on project phase

Position Summary

We are seeking an experienced Staff Product Transfer Project Engineer - Bioprocessing to provide technical leadership for complex biologics manufacturing technology transfer programs between Contract Manufacturing Organizations and internal manufacturing sites.

This role will support sterile injectable biologic drug products and will lead engineering activities across process development, technology transfer, scale-up, qualification, validation, regulatory support, and commercial manufacturing readiness.

The successful candidate will serve as a key technical and engineering liaison between external manufacturing partners and internal Technical Operations, Regulatory Affairs, Quality, Manufacturing, Supply Chain, Validation, and cross-functional project teams. This position is well suited for someone with strong biologics manufacturing knowledge, cGMP experience, technical project leadership, and experience supporting technology transfers in FDA-regulated environments.

Key Responsibilities

Technology Transfer and Engineering Leadership
  • Lead end-to-end bioprocess technology transfer activities between external manufacturing partners and internal manufacturing sites.
  • Support process adaptation, scale-up, equipment qualification, validation, and commercial readiness activities.
  • Provide technical leadership for sterile injectable biologic drug product transfer programs.
  • Partner with internal and external teams to ensure transfer activities are executed in alignment with technical, quality, regulatory, and project requirements.
  • Identify technical risks, project dependencies, process gaps, and execution challenges throughout the transfer lifecycle.
  • Support successful transition of products and processes into commercial manufacturing.
Cross-Functional and CMO Partnership
  • Serve as the primary engineering liaison between Contract Manufacturing Organizations and internal teams.
  • Collaborate with Technical Operations, Regulatory Affairs, Quality, Manufacturing, Supply Chain, Validation, and external partners.
  • Lead technical discussions with internal teams and external manufacturing partners.
  • Communicate project status, risks, technical issues, and recommendations to leadership and stakeholders.
  • Drive issue resolution and ensure alignment across functions during transfer, qualification, validation, and manufacturing readiness activities.
  • Build strong working relationships with CMOs and internal stakeholders to support timely project execution.
Risk Assessment and Technical Problem Solving
  • Conduct engineering gap assessments to identify technical, process, equipment, validation, or documentation risks.
  • Perform technical risk evaluations using structured methodologies such as FMEA.
  • Support root-cause analysis and technical investigations related to process transfer, qualification, validation, or manufacturing readiness challenges.
  • Develop recommendations to address technical gaps and reduce transfer risk.
  • Ensure engineering decisions are supported by sound technical rationale, data, and regulatory expectations.
Validation, Qualification, and Manufacturing Readiness
  • Support IQ, OQ, PQ, GMP, non-GMP, engineering, and PPQ campaign execution.
  • Review protocols, reports, batch records, validation documentation, technical records, and transfer documentation.
  • Ensure documentation aligns with regulatory expectations, quality standards, project timelines, and internal procedures.
  • Support analytical test method transfer activities as needed.
  • Partner with validation, quality, manufacturing, and technical teams to confirm readiness for process execution and commercial production.
  • Provide technical support during manufacturing campaigns, process qualification, and post-transfer activities.
Regulatory and Compliance Support
  • Support regulatory submissions and technical documentation related to manufacturing transfers.
  • Provide technical input for Biologics License Application supplements, inspection readiness, and regulatory justifications.
  • Support documentation and technical rationale for post-approval manufacturing changes.
  • Ensure transfer and engineering activities comply with FDA, EMA, ICH, cGMP, and applicable regulatory expectations.
  • Support inspection readiness through documentation review, technical explanations, and cross-functional preparation.
Change Control and Documentation
  • Manage engineering change strategies, ECOs, and documentation release activities through change control systems.
  • Support change control planning and execution for process, equipment, documentation, analytical method, and manufacturing transfer changes.
  • Prepare, review, and maintain technical documentation, risk assessments, reports, protocols, and project records.
  • Ensure documentation is accurate, complete, traceable, and aligned with quality and regulatory requirements.
  • Perform additional duties as assigned to support Product Transfer and Technical Operations.
Required Qualifications
  • Master's degree or Ph.D. preferred in Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, Engineering, or a related scientific or technical discipline.
  • Bachelor's degree may be considered with significant relevant experience.
  • Minimum of 4 years of engineering experience in biotechnology, biologics, pharmaceutical, medical device, or other highly regulated industries.
  • Minimum of 4 years of experience supporting technology transfer, manufacturing engineering, process engineering, validation, or scale-up in FDA-regulated cGMP environments.
  • Experience supporting biologics manufacturing, bioprocessing, sterile manufacturing, or injectable drug product operations.
  • Strong technical writing, documentation, and communication skills.
  • Strong project management, organizational, and stakeholder-influence skills.
  • Ability to work effectively in highly regulated environments.
  • Ability to travel domestically and internationally up to 25%, depending on project needs.
  • Ability to work in a hybrid role based in Franklin, Tennessee.
Preferred Qualifications
  • Experience working with Contract Manufacturing Organizations.
  • Scientific leadership experience in GMP biologics manufacturing.
  • Experience with sterile injectable biologic drug products.
  • Experience supporting BLA supplements, regulatory submissions, inspection readiness, or post-approval manufacturing changes.
  • Experience with upstream and downstream bioprocessing.
  • Experience with single-use systems, protein formulation, stability, and analytical methods.
  • Experience supporting analytical test method transfers.
  • Experience reviewing or executing IQ, OQ, PQ, PPQ, engineering runs, GMP, and non-GMP campaign documentation.
  • Experience with ECOs, change control systems, documentation release, and technical transfer governance.
  • Experience using FMEA or similar structured risk assessment tools.

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