Manager - Process Development, Downstream

Catalent Pharma Solutions; Alabama; On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

PTO & holidays

401K match

Medical, dental and vision benefits

Tuition Reimbursement

Job summary

Catalent Pharma Solutions in Madison, WI is seeking a Manager – Process Development, Downstream to lead late‑stage development and characterization for protein biologics. The role requires deep downstream expertise, GMP compliance, and robust cross‑functional leadership across MS&T, Manufacturing, and Quality.

The ideal candidate will support PPQ readiness, scale‑up, technology transfer to cGMP manufacturing, and drive disciplined documentation and process control strategies aligned with QbD

Qualifications

• PhD in Biotechnology or related field with minimum of 4 years’ experience in related laboratory work/laboratory leadership role; or MS/MA in Biotechnology or related field with minimum of 8 years’ experience in related laboratory work/laboratory leadership role; or B.S./B.A. in Biotechnology or related field with minimum of 10 years’ experience in related laboratory work/laboratory leadership role
• Leadership experience minimum 4 years
• Downstream process development and scale‑up for protein biologics, including chromatography, filtration (UF/DF, normal flow), viral clearance, and formulation unit operations
• Leadership experience directing personnel and organizational group management, including mentoring and training staff members cross‑functionally
• Experience in applying GMP/GDP in compliance with international regulatory expectations and requirements is a plus
• Process characterization and validation support, including identification of CPPs, CQAs, and establishment of control strategies aligned with QbD principles
• Late‑phase and PPQ readiness support, including authoring or reviewing development reports, characterization protocols, validation strategies, and regulatory‑supporting documentation
• Technology transfer to cGMP manufacturing, including scale‑down model definition, risk assessments, and troubleshooting during manufacturing execution
• Strong working knowledge of cGMP expectations, data integrity, and good documentation practices for biologics manufacturing
• Application of statistical and experimental design tools (e.g., DoE) to support process robustness, lifecycle management, and comparability assessments
• Cross‑functional leadership working with MS&T, Manufacturing, Quality, and Analytical Development to drive aligned technical and execution strategies
• People and technical leadership experience, including mentoring scientists and managing execution across multiple complex programs
• Experience interacting and liaising with internal and external clients, customers, and/or suppliers required
• Experience managing continuous improvement initiatives, lean principles, and 5S is preferred

Responsibilities

• Supervise assigned team’s daily work activities including workload, ensuring training, general guidance to direct reports and across functional groups, and serve as resource for technical/administrative problems
• Hire, train, motivate, lead, develop, and evaluate staff
• Mentor direct reporting people leaders on fundamentals of leadership and career development.
• Take corrective action as necessary on a timely basis and in accordance with company policy
• Ensure compliance with current federal, state, and local regulations.
• Consult with Human Resources Department as appropriate
• Ensure target timelines to deliver results are met and data integrity
• Interact with customers during meetings as a first line in escalations; provide responses to customer’s questions
• Identify and implement new technology/instrumentation for continuous improvement of productivity and throughput
• Author and review technical documents such as Standard Operating Procedures (SOPs), study protocols, and reports
• Communicate effectively and follow detailed written and verbal instruction; ability to clearly communicate and provide mentorship to other groups and clients as necessary
• Ability to provide ideas and introduce new technology for process improvements with the goal of transfer to manufacturing
• Collaborate significantly with cross functional groups including Project Management, Manufacturing, Manufacturing Sciences, and Process Development
• Take responsibility for direct reports’ performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance‑related concerns and issues promptly
• Work with, coach, and support direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee’s career development
• All other duties as assigned

Skills

Downstream process development

Team leadership

cGMP knowledge

DoE & experimental design

Technology transfer

Regulatory documentation

Education

PhD in Biotechnology or related field

MS/MA in Biotechnology or related field with leadership experience

BS/BA in Biotechnology or related field with leadership experience

Tools

Chromatography

Filtration UF/DF

Viral clearance

Job description

Manager - Process Development, Downstream

Position Summary: Work Schedule: M-F 8am-5pm 100% on-site Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s. Catalent Pharma Solutions in Madison, WI is hiring a Manager – Process Development, Downstream. We are seeking an experienced Downstream Process Development Manager to lead late‑stage process development and process characterization activities for protein biologics. The ideal candidate brings deep technical expertise in downstream unit operations and quality‑by‑design principles, along with hands‑on experience supporting late‑phase programs, PPQ readiness, and technology transfer into cGMP manufacturing. This role will provide technical leadership across cross‑functional teams, ensuring robust process understanding, regulatory‑ready documentation, and successful execution from clinical through commercial stages.

The Role:

• Supervise assigned team’s daily work activities including workload, ensuring training, general guidance to direct reports and across functional groups, and serve as resource for technical/administrative problems
• Hire, train, motivate, lead, develop, and evaluate staff
• Mentor direct reporting people leaders on fundamentals of leadership and career development.
• Take corrective action as necessary on a timely basis and in accordance with company policy
• Ensure compliance with current federal, state, and local regulations.
• Consult with Human Resources Department as appropriate
• Ensure target timelines to deliver results are met and data integrity
• Interact with customers during meetings as a first line in escalations; provide responses to customer’s questions
• Identify and implement new technology/instrumentation for continuous improvement of productivity and throughput
• Author and review technical documents such as Standard Operating Procedures (SOPs), study protocols, and reports
• Communicate effectively and follow detailed written and verbal instruction; ability to clearly communicate and provide mentorship to other groups and clients as necessary
• Ability to provide ideas and introduce new technology for process improvements with the goal of transfer to manufacturing
• Collaborate significantly with cross functional groups including Project Management, Manufacturing, Manufacturing Sciences, and Process Development
• Take responsibility for direct reports’ performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance‑related concerns and issues promptly
• Work with, coach, and support direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee’s career development
• All other duties as assigned

The Candidate:

• PhD in Biotechnology or related field with minimum of 4 years’ experience in related laboratory work/laboratory leadership role; or M.S./M.A. in Biotechnology or related field with minimum of 8 years’ experience in related laboratory work/laboratory leadership role; or B.S./B.A. in Biotechnology or related field with minimum of 10 years’ experience in related laboratory work/laboratory leadership role
• Leadership experience minimum 4 years
• Downstream process development and scale‑up for protein biologics, including chromatography, filtration (UF/DF, normal flow), viral clearance, and formulation unit operations
• Leadership experience directing personnel and organizational group management, including mentoring and training staff members cross‑functionally
• Experience in applying GMP/GDP in compliance with international regulatory expectations and requirements is a plus
• Process characterization and validation support, including identification of CPPs, CQAs, and establishment of control strategies aligned with QbD principles
• Late‑phase and PPQ readiness support, including authoring or reviewing development reports, characterization protocols, validation strategies, and regulatory‑supporting documentation
• Technology transfer to cGMP manufacturing, including scale‑down model definition, risk assessments, and troubleshooting during manufacturing execution
• Strong working knowledge of cGMP expectations, data integrity, and good documentation practices for biologics manufacturing
• Application of statistical and experimental design tools (e.g., DoE) to support process robustness, lifecycle management, and comparability assessments
• Cross‑functional leadership working with MS&T, Manufacturing, Quality, and Analytical Development to drive aligned technical and execution strategies
• People and technical leadership experience, including mentoring scientists and managing execution across multiple complex programs
• Experience interacting and liaising with internal and external clients, customers, and/or suppliers required
• Experience managing continuous improvement initiatives, lean principles, and 5S is preferred

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement - Let us help you finish your degree or start a new degree! Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

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Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life‑cycle supply. With time-tested experience in development sciences, delivery technologies, and multi‑modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.