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Biotech Director Of Process Development Jobs (NOW HIRING)

Biovire

Manager, Process Development

Brighton, MI · On-site

$100K - $120K/yr

The RoleReporting to the Director, Pharmaceutical Technologies, the Manager, Process Development ... This role leads a team of Process Engineers and ensures that manufacturing processes are ...

Chobani

Director of Process Engineering

Twin Falls, ID · On-site

Summary The Director of Process Engineering will develop and lead the onsite Area Process Engineering team for Chobani's Idaho production facility. This position will be responsible for ensuring ...

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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.

Executive Director, Process Engineering

Gaithersburg, MD • On-site

AstraZeneca
Pharmaceutical Product Wholesalers • 10K+ employees
Learn more about AstraZenecaexternal

Full-time

Re-posted 15 days ago

AstraZeneca rating

8.4

Company rating: 8.4 out of 10

Based on 45 frontline employees who took The Breakroom Quiz

23rd of 86 rated pharmaceutical

Job description

If you have the passion and the drive to accelerate growth and make people's lives better - then AstraZeneca is the place for you. In Operations we have a big ambition - to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking.
AstraZeneca turns molecules to medicines, bringing our Research & Development pipeline to life through a rigorous process of development, manufacturing, testing and delivery. Operations is accelerating, fast. We are on track for Our Bold Ambition 2030, delivering 15+ new medicines driving us forward across different modalities including biologics, cell therapy, ADCs and small molecules.
Position Summary
We are looking for an experienced Executive Director of Process Engineering to lead our cell therapy process engineering team. The Executive Director will oversee the design, scale-up, and optimization of cell therapy manufacturing processes. This is a new leadership position responsible for building out a team. You will help ensure that our cell therapy products are manufactured, cost-effectively, from early development through commercialization.
The Executive Director will collaborate with teams, including R&D, Quality, Manufacturing, and Regulatory Affairs, to the successful development of process engineering solutions. We are looking for an understanding of cell therapy manufacturing, advanced process technologies, and regulatory requirements, and experience in leadership. You will report to the Vice president of Analytical and Process Development. The position can be based in Gaithersburg, MD or Santa Monica, CA.
Responsibilities
  • Lead the Late-Stage Process Development function for Cell Therapies within the CTO, managing multiple development projects across several locations.
  • Create and deploy global technical standards for cell therapy, focusing on process validation, sterility assurance, raw materials, single-use technology, and packaging, all within established quality systems.
  • Design and oversee process validation, qualification, and monitoring strategies, implementing master validation plans for processes, equipment, and facilities in collaboration with Subject Matter Experts.
  • Build and manage a multi-site organization that supports the product portfolio, ensuring efficient processes, knowledge exchange, and integration of lessons learned.
  • Oversee resource allocation and make strategic "make vs. buy" decisions based on project priorities and technology strategies, adhering to CTO CGT governance processes.
  • Drive innovation by integrating internal and external expertise, incorporating the latest technologies, and leading digital programs aligned with CTO CGT strategies.
  • Ensure compliance with all relevant regulations (e.g., ISEC, GMP, HSE), and manage regulatory submissions, including the creation of source documents and dossier modules.
  • Provide technical leadership for developing new and improved processes for high-quality cell therapy production.
  • Author and review regulatory CMC packages for IND filings and approval applications (BLA/MAA/NDA).
  • Address process development inquiries from health authorities during global product filings and approvals.
  • Oversee and ensure the delivery of process development, qualification, and transfer from Process Development to Operations for GMP manufacturing of clinical and commercial cell therapy products.
  • Fulfil all post-approval commitments for commercial products to health authorities.

Preferred Requirements
  • Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or a related field, or a Master's degree with relevant industry experience.
  • 10+ years of experience in process engineering preferred, with at least 10 years in a leadership role within the biotechnology or pharmaceutical industry with a focus on cell therapy or biologics.
  • Experience in cell therapy or biologics manufacturing, including process design, scale-up, and optimization.

Skills and Competencies
  • Knowledge in GxP compliance and data integrity.
  • Proven track record in managing and leading a large, high-performing team (30+ members) with preferred expertise in CAR-T and human stem cell therapies, biologics, process development, transfer, validation, and automation.
  • Demonstrated ability in developing value-added manufacturing processes from scratch.
  • Diversified experience in a wide spectrum of CMC development suitable for adequately producing cell therapeutics.

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the Gaithersburg, MD or Santa Monica, CA office. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
The annual base salary for this position ranges from $269,000 to $328,900. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Date Posted
05-Sep-2024
Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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About AstraZeneca

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AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. A place built on courage, curiosity and collaboration - we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team. Make a meaningful impact that brings real benefits to society. By applying your knowledge of data, you will help to redefine our industry and ultimately save lives. Work with experts who share a common goal: to accelerate the potential of medicines and the science of tomorrow.

Industry

Pharmaceutical product wholesalers and pharmaceutical and medicine manufacturing

Company size

10,000+ Employees

Headquarters location

Cambridge, Cambridgeshire, GB

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