Sr. Manager/Associate Director, Drug Substance Development & Manufacturing

7+ years

$155,000 - $205,000 USD

San Francisco

10 July 29, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About Calcilytix & BridgeBio Pharma

Calcilytix Therapeutics, an affiliate of BridgeBio Pharma, is focused on developing encaleret (CLTX-305), a negative allosteric modulator of the calcium-sensing receptor (CaSR) aimed at treating Autosomal Dominant Hypocalcemia Type 1 (ADH1), a genetic cause of hypoparathyroidism. Encaleret is currently undergoing a Phase 3 clinical study and has been granted Orphan Drug and Fast Track Designations by the US FDA.

BridgeBio Pharma is a biopharmaceutical company dedicated to discovering, creating, testing, and delivering transformative medicines for patients suffering from genetic diseases and cancers with clear genetic drivers. Since its inception in 2015, BridgeBio has developed a portfolio of over 30 drug development programs ranging from preclinical to late-stage development across various therapeutic areas, including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

BridgeBio is committed to scientific excellence and rapid execution, translating today's scientific discoveries into tomorrow's medicines. The company has U.S. offices in San Francisco, Palo Alto, and Raleigh, with smaller satellite offices throughout the country. Internationally, BridgeBio has offices in Montreal, Canada, and Zurich, Switzerland, and is expanding across Europe.

For more information about our story and company culture, visit us at Calcilytix and BridgeBio.

Senior Manager/Associate Director, Drug Substance Development and Manufacturing

Position Overview

The Senior Manager/Associate Director of Drug Substance Development and Manufacturing will oversee critical scientific, regulatory, and business functions related to process chemistry. Key responsibilities include overseeing late development and launch preparation activities, developing chemical processes for active pharmaceutical ingredients (APIs) and regulatory starting materials (RSMs), process scale-up, technology transfer, and validation of chemical processes. Effective management of Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) is crucial for achieving these goals. The role also involves contributing to the overall strategy and authoring the Module 3 drug substance sections of regulatory submissions.

Key Responsibilities

Lead drug substance development teams, both internally and externally, including managing CROs/CMOs to ensure delivery of final bulk active drug substance of high quality.
Create and distribute technical transfer documents to CROs/CMOs for process development and analytical methods development.
Establish and maintain relationships with CROs/CMOs to meet process development requirements.
Draft, review, and manage contracts with CROs/CMOs, ensuring tasks are completed on time and within budget.
Maintain expertise in chemical processes, manufacturing, and quality controls.
Oversee process development activities to support pharmaceutical formulation development, toxicology testing, clinical trials, and commercial launch.
Ensure chemical processes meet targets for cost, quality, safety, environmental standards, and operability.
Lead problem resolution and process improvement initiatives.
Guide scale-up, process development, and validation for commercial-scale manufacturing.
Provide scientific data and document review for regulatory filings and commercialization.
Foster a culture of continuous improvement and high-performance teamwork.
Collaborate with Quality Assurance (QA) to develop appropriate CMC procedures and ensure product quality.
Contribute to the regulatory strategy for the encaleret program, focusing on drug substance (DS) and drug product (DP) strategy.

Qualifications and Skills

Minimum of a Ph.D. in chemistry or chemical engineering with 7+ years of relevant experience, or a BS/MS with 10+ years of relevant experience.
Proven track record in managing API chemical development, process validation, and manufacturing in support of NDA applications and commercial production.
Significant experience in synthetic organic chemistry and analytical methods development and validation.
Knowledge of FDA and ICH guidelines for INDs/NDAs/MAAs and cGMPs.
Experience in managing CMOs, scientific collaborations, and contracted R&D.
Strong project leadership, attention to detail, and time management skills.
Excellent communication skills, both oral and written.

What We Offer

Patient Days: Opportunities to hear directly from individuals living with the conditions we aim to treat, learning how to improve our efforts.
Company Culture: A focus on putting patients first, independent thinking, radical transparency, valuing every minute, and letting science guide us.
Decentralized Model: Our affiliate structure minimizes bureaucracy, empowering program teams to make decisions.
Career Development: Access to learning resources and opportunities for rapid career advancement.
Compensation & Benefits: Competitive salary, performance bonus, equity, health benefits, flexible PTO, and opportunities to work across multiple therapeutic areas.

Salary Range

$155,000 - $205,000 USD (California-based candidates; ranges may vary for positions in other states).

Commitment to Diversity, Equity & Inclusion

BridgeBio is committed to providing a diverse, inclusive, and equitable work environment.

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Sr. Manager/Associate Director, Drug Substance Development & Manufacturing

Job Description

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