Senior Manager/Associate Director, Drug Product, CMC

COMPANY:

Centessa Pharmaceuticals plc (Nasdaq: CNTA) is a new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa companies are advancing a portfolio of high conviction programs with strong biological validation.

Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.

SUMMARY:

Centessa continues to expand its CMC group and currently seeks a Senior Manager/Associate Director of Drug Product within the CMC group. The successful candidate will have a demonstrated, proven track record of designing high performance formulations as well as managing CROs and CDMOs. The candidate should also have hands-on experience in developing and manufacturing small molecule drug products to support Phase 1 to later stages through commercial launch.  This candidate will actively lead work with various vendors and oversee drug product development and manufacturing across programs to meet company deliverables and timelines.  Travel to vendors both domestically and internationally will be required (10-15%).

KEY RESPONSIBILITIES:

• Manage and guide external vendors, such as Contract Research Organizations (CROs), Contract Development and Manufacturing Organizations (CDMOs), and Contract Manufacturing Organizations (CMOs) to develop phase appropriate oral adult and pediatric drug product formulations and manufacturing process for new chemical entities, pre-clinical through commercialization.
• Ensure appropriate technical, scale-up, and production strategies and timelines are in place for delivery of clinical supply, and ensure technology transfer, validation and regulatory outcomes are met.
• Provide remote or onsite support, as needed, to oversee manufacture of clinical batches at selected CDMOs.
• Apply a QbD approach to design and execute process scale up and robustness studies and associated risk assessments/FMEAs to inform process validation.
• Adhere to cGMP work practices and work closely with the Company’s Quality organization to ensure strict compliance requirements.
• Work closely and collaboratively with cross-functional CMC groups including discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality and regulatory, as well as other CMC functions.
• Author drug product development reports and related sections for IND, IMPD, CTA and NDA filings.

QUALIFICATIONS:

• Thorough understanding of cGMP requirements for pharmaceutical products
• Strong organizational, analytical, and interpersonal skills
• Ability to work independently in a fast-paced dynamic environment with multiple projects.
• Demonstrated ability to coordinate external development (CRO, CDMO, CMO) activities in the development and commercialization of pharmaceutical products.
• Strong decision-making and communication skills and resource management skills in a dynamic environment located across multiple geographies.
• Excellent organizational skills, project management skills and detail-orientated leadership approach
• Must be willing to travel both domestically and internationally (10-15%)

EXPERIENCE:

• Bachelor’s degree in Pharmaceutical Sciences or a related field. MS or Ph.D is preferred.
• 5-8 years of formulation industry experience in oral delivery of small molecules supporting pre-formulation through commercialization.
• Demonstrated understanding of technical aspects associated with the development and manufacture of poorly soluble (BCS Class II/IV) small molecule compounds for oral delivery.
• A strategic thinker with strong result-orientation, and sense of urgency to deliver quality results on time and in a high ethical and professional manner.
• Excellent communication and interpersonal skills with the ability to build, sustain, and manage internal and external relationships and communicate complex issues and concepts at all levels.
• Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them.
• Resilient and able to work well in a demanding, innovative and fast paced environment.
• Strong verbal and written communications skills, ability to express oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
• Sound knowledge of pharmaceutical and engineering principles in liquid and solid dosage form development for both clinical and commercial scales.
• Experienced in writing, reviewing, and approving CMC sections of regulatory filings from early-stage development through commercial.
• Strong organizational skills and attention to detail

POSITION: Full-Time, Exempt, Remote, and Travel

EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.