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 ...
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Process Development Manager information
See Missouri salary details
$75.3K is the 25th percentile. Wages below this are outliers.
$70.3K - $78.6K
42% of jobs
The median wage is $81.4K / yr.
$78.6K - $86.8K
23% of jobs
$89.8K is the 75th percentile. Wages above this are outliers.
$86.8K - $95K
27% of jobs
$95K - $103.3K
2% of jobs
$103.3K - $111.5K
0% of jobs
$111.5K - $119.7K
0% of jobs
$119.7K - $128K
0% of jobs
$128K - $136.2K
0% of jobs
$136.2K - $144.4K
2% of jobs
$144.4K - $152.6K
2% of jobs
$152.6K - $160.9K
2% of jobs
$70.3K
$90.5K
$160.9K
How much do process development manager jobs pay per year?
What jobs pay 4000 a week without a degree?
What does a process development manager do?
What are some common challenges faced by a Process Development Manager, and how can they be addressed?
What is the difference between Process Development Manager vs Process Engineer?
| Aspect | Process Development Manager | Process Engineer |
|---|---|---|
| Responsibilities | Oversees process improvement projects, manages teams, develops strategies for scalable processes | Designs, tests, and implements specific manufacturing processes, focuses on technical execution |
| Required Credentials | Bachelor's or Master's in Engineering, experience in process management, certifications like Six Sigma | Bachelor's in Engineering or related field, technical skills, certifications like Lean or Six Sigma |
| Work Environment | Leadership roles in manufacturing or R&D settings, cross-functional collaboration | Hands-on technical work in manufacturing or laboratory settings |
| Industry Usage | Common in manufacturing, pharmaceuticals, biotech industries | Widely used in manufacturing, chemical, and industrial sectors |
The Process Development Manager focuses on strategic oversight and team leadership for process improvements, while the Process Engineer handles technical process design and implementation. Both roles require similar credentials and are integral to manufacturing industries, but differ in scope and responsibilities.
What jobs pay $500,000 a year in the US?
What are the key skills and qualifications needed to thrive as a Process Development Manager, and why are they important?
Is BD manager a stressful job?
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Full-time
Posted 6 days ago
Job description
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.
#LI-Onsite
California residents should review our Notice for California Employees and Applicants before applying.
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees-regardless of format-without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
About Kindeva Drug Delivery
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Woodbury, MN, US
Year founded
2020