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Process Development Leader Jobs (NOW HIRING)

Sr. Process Development Engineer

Waltham, MA ยท On-site

$140K - $154K/yr

Join the Alkermes Process Development team as Senior Engineer, where you will provide technical leadership and support the development of innovative small molecule pharmaceutical dosage forms. You ...

... training processes and programs at the site. The role develops and implements the initiatives to ... leadership development roles. 8. Designs and/or implement content and curricula, blending ...

Process Development Engineer 2

San Diego, CA ยท On-site

$78K - $131K/yr

Execute process development experiments and characterization studies to support product development ... Industry-leading organization committed to employees, customers, and communities. Equal Opportunity ...

... training processes and programs at the site. The role develops and implements the initiatives to ... leadership development roles. 8. Designs and/or implement content and curricula, blending ...

Films Process Development Engineer

New York, NY ยท On-site +1

$107K - $182K/yr

Micron Technology is a world leader in innovating memory and storage solutions that accelerate the ... Experience Bringing to bear Artificial Intelligence for data analysis or process development The US ...

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How much do process development leader jobs pay per year?

As of Sep 13, 2026, the average yearly pay for process development leader 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.

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Infographic showing various Process Development Leader 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 91% Physical, 3% 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 โ€ข On-site

Arrowhead Pharmaceuticals
Pharmaceutical and Medicine Manufacturingย โ€ขย 201 - 500 employees

$140K - $165K/yr

Full-time

Re-posted 6 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
$140,000-$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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