Catalent Pharma Solutions Inc

Director - Process Development, Downstream & Upstream

Catalent Pharma Solutions Inc • $130K — $160K *
Madison, WI 53711In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Reposted 1 week ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in STEM with 15+ years or Master's with 12+ years or Doctorate with 8+ years of experience.
  • 6+ years of leadership experience in biologics process development and manufacturing.
  • Deep understanding of drug development and lifecycle support.
  • Excellent written and verbal communication skills, able to simplify complex concepts for diverse audiences.
  • Familiarity with internal leadership development programs may substitute for external experience.

Responsibilities

  • Lead and develop Process Development teams, managing 2-10 direct reports.
  • Define and execute department strategy aligned with business and scientific goals.
  • Oversee the creation of scalable expression, purification, and product quality processes.
  • Support manufacturing with technology transfer, investigations, and assessments.
  • Collaborate with clients and project management to meet timelines and deliverables.
  • Lead strategic initiatives and process improvement across multiple sites.

Benefits

  • Defined career path with regular performance reviews.
  • Inclusive company culture prioritizing diversity.
  • Promotion opportunities in a growing organization focused on health.
  • Competitive PTO and 8 paid holidays.
  • Medical, dental, and vision benefits from day one.
  • Tuition reimbursement for continued education.
Full Job Description
Position Summary:

We have an opportunity for a Director, Process Development, to join our team and lead the Process Development organization. This role is responsible for advancing biologics process development from early-phase programs through commercial readiness while ensuring successful transfer into manufacturing. You will deliver scalable upstream and downstream processes, support manufacturing execution, and align cross-functional teams and clients to meet development timelines and business objectives. This position provides technical, operational, and people leadership across multiple functions and sites, driving strategic initiatives, process improvements, and organizational performance.

Location: Madison, WI

100% Onsite

The Role:
  • Work closely with the Manufacturing Sciences group to ensure successful transfer of processes from PD into manufacturing in order to support early phase through commercial manufacturing activities.
  • Work closely with prospective and existing clients, as well as Project Management, to ensure client expectations, scheduling, and timelines are met.
  • Apply technical, functional, business, and industry expertise to design experiments and define project scopes; provide scientific and strategic consultation to site and executive leadership; and lead multiple functions and focus areas across site disciplines.
  • Actively define and execute on strategic direction of the department by recommending expansion or curtailment of investigations based on experimental results or scientific information.
  • Lead Process Development teams and manage 2-10 direct reports which may include principal level scientists and people leaders.
  • Support manufacturing through process transfer, technology transfer, investigations, and facility fit assessments.
  • Direct the development of scalable processes to support optimal expression, purification, and product quality attributes for both antibodies, recombinant proteins, and other biomolecules.
  • Responsible for execution of production batches and supporting manufacturing up to sX2000L scale in SUBs.
  • Identify, evaluate, and execute on process improvements to increase existing capabilities.


The Candidate:
  • Bachelor's degree in STEM discipline with 15 years of biopharmaceutical manufacturing experience; OR Master's degree with 12 years' experience; OR PhD with 8 years' experience and 6+ years in leadership roles.
  • Able to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process.
  • Experienced in all aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones.
  • Well organized with ability to handle and direct multiple activities within the site or across multiple sites simultaneously.
  • Excellent written and verbal communication skills with internal and external customers.
  • Ability to communicate complex technical information to non-technical audiences.
  • Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.


Preferred Skills & Background
  • Expertise in mammalian cell culture and upstream process development.
  • Expertise in downstream process development and process characterization.
  • Experience supporting technology transfer and commercial manufacturing readiness.
  • Strong stakeholder management and executive influence skills.
  • Strong coaching, mentoring, and talent development capabilities.
  • Experience leading customer-facing technical discussions and issue resolution.
  • Experience supporting production in single-use bioreactor environments.


Why You Should Join Catalent:
  • Defined career path and annual performance review and feedback process.
  • Diverse, inclusive culture.
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
  • Competitive paid time off plus 8 paid holidays.
  • Community engagement and green initiatives.
  • Medical, dental, and vision benefits effective day one of employment.
  • Tuition Reimbursement.

About Catalent Pharma Solutions Inc

Catalent Pharma Solutions Inc is a global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. The company operates in four segments: Softgel and Oral Technologies, Biologics, Oral and Specialty Delivery, and Clinical Supply Services. Catalent Pharma Solutions serves customers in various industries, including pharmaceuticals, biotechnology, and consumer health. The company was founded in 2007 and is headquartered in Somerset, New Jersey.
Learn more about Catalent Pharma Solutions Inc
Size
14,000 employees
Industry
Pharmaceuticals & Biotech
Founded
2007
* Ladders Estimates

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