layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Principal Scientist - Process Development, Downstream at Catalent Pharma Solutions | LAYIQ

Technical Leadership & Scientific Strategy: Serve as the scientific lead for downstream process development programs supporting monoclonal antibodies ( mAbs ), multispecific antibodies, and recombinant protein therapeutics. Provide strategic direction, scientific consultation, and technical oversight across multiple client programs.
Process Development Oversight: Guide the design, development, optimization, and characterization of downstream processes, including chromatography, ultrafiltration/diafiltration (UF/DF), viral filtration, clarification, and cell removal methodologies to enable successful clinical and commercial manufacturing.
Client Partnership & Program Management: Act as the primary technical contact for client development projects, leading meetings, communicating project status, providing scientific rationale, and ensuring alignment between technical execution and program objectives .
Technology Transfer & Commercial Readiness: Lead technology transfer activities, scale-up strategies, process characterization studies, and viral clearance programs to support progression from development through cGMP manufacturing.
Cross-Functional Leadership: Collaborate with Process Development, MS&T, Manufacturing, Quality, and Analytical teams to drive project execution, troubleshoot technical challenges, and ensure successful project delivery.
Technical Documentation & Review: Author, review, and approve technical documents including protocols, reports, SOPs, batch records, and client-facing deliverables while ensuring compliance with Good Documentation Practices (GDP) and regulatory expectations.
Innovation & Continuous Improvement: Evaluate emerging technologies, identify opportunities for process enhancement, and contribute to the advancement of scientific capabilities, service offerings, and best practices within the organization.
Mentorship & Scientific Development: Mentor scientists and technical staff, providing coaching, guidance, and knowledge-sharing to support team growth and development.
Other responsibilities as needed.
Required Qualifications
Ph.D. in Biotechnology, Biochemical Engineering, Chemical Engineering, Biology, or a related scientific discipline with a minimum of 8 years of relevant industry experience; master's degree with a minimum of 12 years of experience; or bachelor's degree with a minimum of 15 years of experience.
Demonstrated expertise in development and commercialization of mAbs , multispecifics , recombinant proteins, or other complex biologic therapeutics.
Strong expertise in chromatography, filtration, UF/DF, viral filtration, and cell removal technologies.
Proven experience leading technical programs and serving as a client-facing scientific representative.
Demonstrated knowledge of cGMP environments, technology transfer, process characterization, and scale-up.
Excellent scientific communication, problem-solving, and project management skills.

Experience in a biopharmaceutical, biotechnology, or CDMO environment.
Track record of leading cross-functional teams and mentoring scientific staff.
Experience supporting multiple client programs simultaneously.
Expertise in viral clearance studies, late-stage process development, and commercial manufacturing readiness.
Strong business acumen and ability to build client relationships.
Why you should join Catalent
Opportunity to play a key role in driving growth within a global CDMO leader.
Competitive compensation package, including incentive opportunity.
Day-one medical, dental, and vision coverage.
401(k) with company match .
Tuition reimbursement and professional development opportunities.
Generous paid time off and holiday schedule ( 152 hours + 8 holidays)
Collaborative, mission-driven culture focused on improving patient outcomes worldwide.
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.
Visit Catalent Careers to explore career opportunities.
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 DisabilityAccommodations@catalent.com . 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. Thank you.
Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE .
Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.
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.

Principal Scientist - Process Development, Downstream

Employer job description

About Catalent Madison

Key Responsibilities

Preferred Qualifications

About this listing