Staff Process Engineer

Initial Therapeutics, Inc.; Tustin (CA); On-site; USD 170,000 - 200,000; Full time

Job summary

Syner-G is seeking a Staff Process Engineer / MSAT Technology Transfer Lead with 10–15+ years of biologics experience to oversee ~10 concurrent monoclonal antibody technology transfers.

You will drive handoff to GMP manufacturing, PPQ, and commercialization readiness, partnering across MSAT, Process Development, Manufacturing, Quality, Regulatory, and PM to ensure timely milestones and robust risk management.

Qualifications

• 10–15+ years MSAT/process engineering/tech transfer experience in biologics.
• Experience managing multiple concurrent technology transfer programs for biologics (mAbs preferred).
• Deep expertise in upstream and downstream biologics manufacturing including mammalian cell culture, chromatography, filtration, UF/DF.
• Strong GMP, validation, PPQ knowledge for commercial biologics manufacturing.
• Proven cross-functional leadership and program management experience.

Responsibilities

• Lead portfolio of ~10 concurrent mAb technology transfer programs with milestones and risks.
• Drive tech transfer from process handoff through GMP manufacturing and PPQ.
• Partner with MSAT leadership; develop governance, reporting metrics, and escalation paths.
• Provide SME in mAb manufacturing: cell culture, chromatography, filtration, UF/DF, drug substance production.
• Support transfer strategies, validation planning, risk assessments, and commercialization planning.
• Develop and implement risk-based validation and PPQ strategies using data and QA requirements.
• Assess CPPs and CQAs; ensure proper control strategies.
• Collaborate with MSAT, Process Development, Manufacturing, Quality, QA, Regulatory, and PM teams.
• Provide hands-on technical support for troubleshooting and transfer activities.
• Lead commissioning, qualification, startup, and operational readiness for transfers.
• Develop scalable transfer procedures, templates, and best practices for portfolio growth.
• Identify and mitigate technical, operational, scheduling, and resource risks.
• Drive continuous improvement for transfer effectiveness and throughput.
• Mentor engineers and serve as advisor to stakeholders.

Skills

MSAT leadership

cross-functional leadership

portfolio governance

process validation

risk management

project management

monoclonal antibodies

statistical analysis

Education

BS or MS in Chemical/Biochemical/Bioprocess Engineering or related

Job description

POSITION OVERVIEW

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 a portfolio of monoclonal antibody (mAb) drug substance technology transfers. This role will be responsible for managing approximately 10 concurrent technology transfer programs, driving cross-functional execution from process transfer through GMP manufacturing and PPQ, while ensuring technical readiness, risk mitigation, and milestone achievement.

The successful candidate will serve as a strategic partner to MSAT leadership, establishing governance, portfolio reporting, resource planning, and escalation processes that improve execution visibility and accountability. Leveraging deep expertise in mammalian cell culture, downstream purification, process validation, and commercial manufacturing, the Staff Process Engineer will support transfer strategies, validation planning, process risk assessments, and commercialization activities. The ideal candidate will combine strong program leadership capabilities with hands‑on process development and manufacturing science experience to support technical troubleshooting and execution as needed.

KEY RESPONSIBILITIES

• Lead a portfolio of approximately 10 concurrent mAb drug substance technology transfer programs, managing timelines, milestones, deliverables, risks, and cross‑functional dependencies.
• Drive technology transfer activities from process handoff through GMP manufacturing, PPQ execution, and commercial readiness.
• Serve as a strategic partner to MSAT leadership by developing governance structures, portfolio reporting metrics, resource planning tools, and escalation pathways to improve transfer execution and visibility.
• Provide technical leadership and subject matter expertise in monoclonal antibody manufacturing, including mammalian cell culture, chromatography, filtration, UF/DF, and drug substance production.
• Support technology transfer strategy development, technical readiness assessments, process fit‑gap evaluations, and commercialization planning.
• Develop and implement risk‑based process validation and PPQ strategies utilizing process characterization data, prior process knowledge, and product quality requirements.
• Evaluate process risks and critical process parameters (CPPs), ensuring appropriate control strategies and confirmation of Critical Quality Attributes (CQAs).
• Collaborate closely with MSAT, Process Development, Manufacturing, Quality, QA, Supply Chain, Regulatory Affairs, and Project Management teams to ensure transfer readiness and successful execution.
• Provide hands‑on technical support, troubleshooting, and process assessment activities when required, leveraging previous laboratory, process development, or manufacturing experience.
• Lead commissioning, qualification, startup, and operational readiness activities associated with technology transfer and process implementation.
• Develop and maintain scalable technology transfer procedures, templates, tools, and best practices to support a growing portfolio of commercial and late‑stage programs.
• Identify and mitigate technical, operational, scheduling, and resource risks while advancing programs toward key milestones.
• Drive continuous improvement initiatives focused on transfer effectiveness, process robustness, manufacturing throughput, and operational excellence.
• Mentor engineers and technical staff while serving as a trusted advisor to internal stakeholders and client leadership teams.

QUALIFICATIONS AND REQUIREMENTS

Education

• BS or MS in Chemical Engineering, Biochemical Engineering, Bioprocess Engineering, Biotechnology, or a related technical discipline preferred.

Technical Experience

• 10–15+ years of experience in MSAT, process engineering, process development, technology transfer, or biologics manufacturing within biotechnology or pharmaceutical organizations.
• Demonstrated experience managing multiple concurrent technology transfer programs for biologic products, preferably monoclonal antibodies.
• Extensive expertise in upstream and downstream biologics manufacturing processes, including mammalian cell culture, chromatography, viral clearance operations, filtration, and UF/DF.
• Hands‑on experience supporting process development, manufacturing investigations, scale‑up, process characterization, and technology transfer activities.
• Strong knowledge of GMP manufacturing, process validation, PPQ execution, lifecycle validation, and regulatory expectations for commercial biologics manufacturing.
• Proven leadership of cross‑functional technical teams and complex manufacturing or commercialization programs.
• Experience developing portfolio governance, resource planning, risk management, and program reporting frameworks is highly desirable.
• Prior MSAT leadership or technical program management experience supporting commercial biologics products preferred.

Technical Skills

• Deep understanding of mAb drug substance manufacturing processes and technology transfer methodologies.
• Strong knowledge of process validation, PPQ strategy development, process characterization, CPP/CQA assessment, and risk management principles.
• Experience with manufacturing scale‑up, process monitoring, statistical analysis, and process performance evaluation.
• Ability to assess technical readiness, identify process risks, and develop mitigation strategies across multiple programs.
• Strong project and portfolio management capabilities, including management of schedules, resources, budgets, and competing priorities.
• Excellent communication, stakeholder management, leadership, and influencing skills.
• Ability to operate effectively in fast‑paced, highly matrixed environments supporting multiple simultaneous programs.

ESSENTIAL FUNCTIONS

Physical Demands

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

TOTAL REWARDS PROGRAM

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company‑paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

COMPENSATION

The expected salary range for this position is $170,000 to $200,000 yearly. Actual pay will be determined based on experience, qualifications, geographic location, and other job‑related factors permitted by law.

Syner‑G is currently unable to sponsor or take over sponsorship of an employment visa at this time.

LEGAL STATEMENT

Syner‑G is proud to be an Equal Employment Opportunity and affirmative action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or any other basis prohibited by applicable law. Syner‑G is an E‑Verify employer.