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Biotech Director Of Process Development Jobs (NOW HIRING)

Nokia

Process Development Engineer

Allentown, PA · On-site

$88K - $163K/yr

The person should have hands-on experience with process development and be well versed in ... Design of Experiments (DOE), Failure Mode Effects Analysis (FMEA), innovative data reduction, and ...

Oxford Biomedica

Director, Business Development, East Coast Location: Home Based, US Company: oxfordbiom Join Us in ... of biologics process development and GMP manufacturing projects in Pharma & Biotech.

MaverickX

Director

Austin, TX · On-site

... edge biotechnology products to the world's most critical industries. The Role We are seeking a ... Lead translation of biological processes from laboratory development through pilot and commercial ...

Teledyne FLIR LLC

Process Development Engineer

Goleta, CA · On-site

$90K - $121K/yr

As part of process development, hands-on wafer fabrication and characterization of pilot lots is required. This is the right place for a self-directed, goal-oriented, collaborative engineer. The work ...

FLEXSYS

Process Development Chemist

Akron, OH

Description About Flexsys Flexsys is the world's leading producer of high-quality rubber chemicals ... Plan, direct, and review work performed by development partners to ensure technical quality ...

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Biotech Director Of Process Development information

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How much do biotech director of process development jobs pay per year?

As of Sep 10, 2026, the average yearly pay for biotech director of process development in the United States is $95,708.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,000.00 and $114,500.00 per year, depending on experience, location, and employer.

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Infographic showing various Biotech Director Of Process Development job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 82% Full Time, 14% Part Time, and 3% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $95,708 per year, or $46 per hour.

Product Process Validation Manager

Bridgeton, MO • On-site

kindeva
Pharmaceutical and Medicine Manufacturing
Learn more about kindevaexternal

Full-time

Re-posted 11 days ago

Kindeva rating

6.7

Company rating: 6.7 out of 10

Based on 9 frontline employees who took The Breakroom Quiz

Job description

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The is an exciting opportunity as Product Process Validation Manager is a key member of the Manufacturing Science & Technology (MS&T) organization, responsible for leading process validation strategy and execution across the product lifecycle. This role oversees the design, authorship, and facilitation of technology transfer activities, Process Performance Qualification (PPQ) protocols and reports, and supporting ongoing Continued Process Verification (CPV). The manager partners closely with Process Development, Quality, Manufacturing, and Regulatory Affairs to ensure robust, compliant, and efficient validation programs. This position reports directly to the Director of MS&T.

Role Responsibilities

Process Validation & PPQ

  • Lead the development, authorship, and execution of process validation strategies in alignment with regulatory expectations (e.g., FDA, EMA, ICH Q8–Q11).
  • Write, review, and approve PPQ protocols, sampling plans, risk assessments, and final reports.
  • Facilitate cross-functional PPQ readiness, including coordinating activities with Manufacturing, Quality Control, and Quality Assurance.
  • Ensure validation deliverables meet internal standards and external regulatory requirements.

Technology Transfer

  • Serve as the MS&T lead for technology transfer of new products, processes, or scale-up activities into manufacturing.
  • Develop and maintain tech transfer plans, process descriptions, and knowledge transfer documentation.
  • Drive process fit-gap assessments, risk analyses, and mitigation strategies.
  • Support equipment and facility readiness, including URS development and process capability assessments.

Continued Process Verification (CPV)

  • Partner with data analytics and quality teams to monitor process performance, identify trends, and drive data-based decision-making.
  • Lead investigations and corrective actions related to process performance deviations or CPV signals.

Cross-Functional Leadership

  • Collaborate with Process Development to translate laboratory-scale processes into robust, scalable manufacturing processes.
  • Support Regulatory Affairs with process validation content for submissions, responses to regulatory queries, and inspections.
  • Provide technical leadership during audits and regulatory inspections.
  • Mentor and guide junior MS&T staff in validation and tech transfer best practices.

Documentation & Compliance

  • Ensure all validation and tech transfer documentation is accurate, complete, and audit-ready.
  • Maintain strong alignment with internal quality systems, change control, and document management processes.
  • Champion continuous improvement initiatives to enhance validation efficiency and process robustness.

Basic Qualifications

  • Bachelor’s or Master’s degree in Engineering, Life Sciences, Biotechnology, or related field.
  • 7+ years of experience in biopharmaceutical or pharmaceutical manufacturing, MS&T, process validation, or related technical functions.
  • Demonstrated expertise in PPQ, CPV, and technology transfer.
  • Strong understanding of cGMP regulations and global validation guidelines.
  • Excellent technical writing, communication, and project management skills.

Preferred

  • Experience with biologics, cell therapy, gene therapy, or aseptic manufacturing.
  • Familiarity with statistical tools (e.g., JMP, Minitab) for process analysis.
  • Prior leadership or team management experience.
  • Experience supporting regulatory inspections.

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