Senior Director, Drug Product CMC

Description

of Role Centessa is seeking an Senior Director of Drug Product within the CMC group. The successful candidate will have a demonstrated proven track record of designing high performance nonclinical and clinical formulations as well as managing CROs and CDMOs. The candidate should also have hands-on experience in developing and manufacturing nonclinical and clinical small molecule drug products to support Phase I to Phase III. Reporting to the Executive Director CMC this position will primarily lead work with external vendors and oversee nonclinical formulation development with flexibility to support clinical drug product development across programs to meet company deliverables and timelines. Travel to domestic and international vendors required.

Key Responsibilities

Directly manage external vendors such as Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) to Execute physiochemical characterization and pre-formulation studies for New Chemical Entities (NCEs). Design and develop nonclinical formulations of drug candidates (oral subcutaneous and intravenous) to ensure stability bioavailability and effective drug delivery in animal models. Design and oversee execution of nonclinical formulation stability and compatibility studies. Support clinical formulation development of oral solid dosage forms as needed. Author and/or review and approve development and dose preparation protocols and reports. Review formulation related sections of protocols and reports associated with Pharmacokinetic (PK) Pharmacodynamic (PD) and safety studies. Represent CMC and provide nonclinical formulation DS and DP stability and supply guidance at internal and external cross functional team meetings. Coordinate shipments in support of nonclinical and Clinical development supply requirements to various CDMO and CRO sites. Assist in compiling formulation-related documentation for regulatory submissions (e.g. IND CTA) to meet nonclinical development 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.

Qualifications

Advanced degree in Chemistry Pharmaceutical Sciences or a related discipline Ph.D. strongly preferred. 10+ years of drug product/formulation development experience supporting nonclinical and clinical programs with expertise across oral subcutaneous and intravenous dosage forms for small molecules. Deep technical expertise in the development and manufacture of poorly soluble (BCS Class II/IV) compounds including formulation strategies for oral and parenteral delivery. Strong understanding of pharmaceutical sciences and engineering principles related to liquid and solid dosage form development from early-stage development through clinical and commercial manufacturing. Working knowledge of analytical and solid-state characterization techniques including HPLC/UPLC XRPD DSC TGA DVS and related methodologies. Experience managing external development and manufacturing partners (CROs CDMOs and CMOs) and a solid understanding of cGMP requirements. Proven ability to lead multiple complex programs in a fast-paced environment with strong project management prioritization resource management and organizational skills. Excellent communication presentation and interpersonal skills with the ability to influence stakeholders build productive internal and external partnerships and communicate complex scientific concepts to diverse audiences. Strategic hands-on leader with strong decision-making and problem-solving capabilities demonstrated resilience and a track record of delivering high-quality results with urgency and integrity. Willing and able to travel domestically and internationally as needed.

Compensation

The annual base salary range for the Sr. Director level position is $165000.00 to $250000

• Individual compensation within this range will be determined based on a variety of factors including qualifications skills relevant experience job knowledge and location. In addition to base pay this role is eligible for a discretionary annual bonus. The Company also offers a comprehensive benefits package which includes a 401(k) plan company-sponsored medical dental vision and life insurance generous paid time off and a health and wellness program.

Work Location

The (Senior) Director Drug Product CMC role is based in the US with occasional travel POSITION Full-Time Exempt EEOC Statement Centessa Pharmaceuticals a wholly owned subdisary of Eli Lilly and Company 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. We will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law. Please note We will not assign referral rights for any unsolicited resumes from recruitment agencies.