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Biotech Process Development Manager Jobs (NOW HIRING)

FLEXSYS

Process Development Chemist

Akron, OH

Manage and collaborate closely with external contract research organizations (CROs) executing synthesis, process development, scale-up, and intellectual property development. ? Plan, direct, and ...

PSC Biotech

Business Development Manager

Dallas, TX · On-site

PSC Biotech provides the life sciences with essential services to ensure that health care products ... Your Role The Business Development Manager is a quota-bearing individual contributor responsible ...

FLEXSYS America

Process Development Chemist

Akron, OH · On-site

Manage and collaborate closely with external contract research organizations (CROs) executing synthesis, process development, scale-up, and intellectual property development. ? Plan, direct, and ...

Novelis

Process Development Engineer

Bay Minette, AL

The Process Development Engineer will develop and implement new products and processes to improve ... A proven track record to effectively lead and manage projects involving multiple people at multiple ...

Marmon

Process Development Engineer

Harlingen, TX · On-site

... Manager in directives outlined by him/her for improving the plant, including, but not limited to ... Process Development Responsibilities: Perform new process development, including, but not limited ...

Eastman

Process Development Engineer

Fieldale, VA

Interface with Project managers and teams to clearly understand the needs to advance the project ... in development and scale-up of new products/processes * Provide scale-up project leadership ...

Eastman

Process Development Engineer

Martinsville, VA · On-site

Interface with Project managers and teams to clearly understand the needs to advance the project ... development and scale‑up of new products/processes. * Provide scale‑up project leadership ...

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Biotech Process Development Manager information

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$75K

$96.4K

$171.5K

How much do biotech process development manager jobs pay per year?

As of Sep 10, 2026, the average yearly pay for biotech process development manager in the United States is $96,440.00, according to ZipRecruiter salary data. Most workers in this role earn between $80,000.00 and $96,500.00 per year, depending on experience, location, and employer.

What does a Biotech Process Development Manager do?

A Biotech Process Development Manager oversees the design, optimization, and scale-up of processes used to manufacture biotechnological products such as pharmaceuticals, vaccines, or biologics. They manage teams of scientists and engineers to develop efficient, cost-effective, and regulatory-compliant production methods. Their work involves troubleshooting, process improvement, technology transfer, and ensuring quality standards are met throughout development. Additionally, they collaborate with other departments like quality assurance, regulatory affairs, and manufacturing to ensure successful product commercialization.

What are the key skills and qualifications needed to thrive as a Biotech Process Development Manager?

To thrive as a Biotech Process Development Manager, you need a solid background in bioprocess engineering, biology or chemistry, and experience in process scale-up and optimization, typically supported by an advanced degree. Familiarity with bioreactors, chromatography systems, and regulatory compliance tools such as GMP documentation is essential, along with certifications like Six Sigma or PMP being advantageous. Strong leadership, project management, and problem-solving skills help drive cross-functional teams and ensure process efficiency. These competencies are crucial for developing robust manufacturing processes, ensuring product quality, and meeting regulatory standards in a competitive industry.

What are some common challenges faced by a Biotech Process Development Manager, and how can they be addressed?

A Biotech Process Development Manager often encounters challenges such as scaling up laboratory processes to commercial production, ensuring regulatory compliance, and maintaining cross-functional communication. Addressing these challenges requires strong project management skills, a deep understanding of both upstream and downstream processing, and the ability to collaborate effectively with R&D, quality assurance, and manufacturing teams. Proactive problem-solving and continuous process optimization are key to overcoming technical hurdles and ensuring smooth technology transfer to manufacturing.

What are popular job titles related to Biotech Process Development Manager jobs?

For Biotech Process Development Manager jobs, the most frequently searched job titles are:

Infographic showing various Biotech Process Development Manager 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 $96,440 per year, or $46.4 per hour.

Senior Manager, Process Development

Verona, WI • On-site

Arrowhead Pharmaceuticals
Pharmaceutical and Medicine Manufacturing • 201 - 500 employees
Learn more about Arrowhead Pharmaceuticalsexternal

$150K - $165K/yr

Full-time

Re-posted 3 days ago

Key responsibilities

  • Define and defend regulatory starting material designations for synthetic routes in collaboration with Regulatory Affairs.

  • Provide technical review and oversight of synthetic routes, process chemistry, and impurity control strategies for small molecules.

  • Manage relationships with CMOs and raw material/starting material suppliers, serving as the primary technical point of contact.

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
We are seeking a Senior Manager, Process Development on our Late Phase Development team to lead the strategy and execution of raw material manufacturing, regulatory classification, and supply for our oligonucleotide programs. This individual will own the regulatory starting material (RSM) strategy, provide technical oversight of small molecule synthesis, and manage outsourced manufacturing relationships with contract manufacturing organizations (CMOs) and raw material suppliers. The ideal candidate combines strong chemistry fundamentals with regulatory acumen and proven vendor/CRO/CMO management experience.
This role is full-time onsite, 5 days a week in Verona, WI.
Responsibilities
  • Define and defend regulatory starting material designations for synthetic routes in collaboration with Regulatory Affairs, in alignment with ICH Q11
  • Author and review RSM justification sections for regulatory filings (IND/IMPD, NDA, MAA, etc.)
  • Evaluate synthetic route changes for their impact on RSM designation and regulatory strategy
  • Provide technical review and oversight of synthetic routes, process chemistry, and impurity control strategies for small molecules
  • Assess raw material and starting material specifications to ensure fitness for intended use and consistency with quality target product profiles
  • Support technology transfer of synthetic processes from development to kilo-scale manufacturing
  • Manage day-to-day relationships with CMOs and raw material/starting material suppliers, serving as the primary technical point of contact
  • Lead supplier selection onboarding for raw materials and starting materials
  • Manage PD scientists and assists in the prioritization and management of work flow
  • Provides leadership, technical guidance, and mentoring and development of PD scientists
  • Prepare technical reports, presentations, SOPs, Work Instructions, and procedures
  • Approve technical documentation and workflows
  • Work with cross-functional teams (Process Development, QA, Regulatory, Discovery, AD, Manufacturing, PM, and others as needed) to develop and meet project goals and deliverables
  • Work with third party vendors and CDMOs to meet project deliverables.
  • Monitor and report progress of PD project deliverables within agreed project timelines

Requirements
  • Ph.D. in Organic Chemistry or a related field with 5+ years, M.S. with 10+ years, or B.S. with 12+ years of relevant industry experience in chemistry.
  • Demonstrated expertise with organic chemistry theory and practice.
  • Demonstrated experience with pharmaceutical drug substance development and processes

Preferred
  • PhD or Master's Degree
  • Experience with regulatory interactions (meetings, information requests, filings) related to CMC/starting materials
  • Familiarity with GMP requirements for raw material and API manufacturing
  • Prior people management or team leadership experience

Wisconsin pay range
$150,000-$165,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
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