Sr. Manager/Associate Director, Drug Substance Development - San Francisco, United States - BridgeBio

Description

Calcilytix Therapeutics , an affiliate of BridgeBio Pharma, is developing encaleret (CLTX-305), a negative allosteric modulator of the calcium-sensing receptor (CaSR) for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1), a genetic cause of hypoparathyroidism.

Encaleret is currently being evaluatedinaPhase 3clinical study and has received Orphan Drug and Fast Track Designations from the US FDA.BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers.

We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients.

Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aims to translate todays discoveries into tomorrows medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.

The Senior Manager/Associate Director, Drug Substance Development and Manufacturing will oversee key scientific, regulatory, and business functions pertaining to process chemistry for the organization.

Responsibilities include oversight of late development/launch preparation activities including (but not limited to): the development of 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 CROs and CMOs will be a key strategy and activity required to accomplish the functions mentioned.

The position will also contribute to overall strategy and authoring of Module 3 drug substance sections of regulatory submissions by provision of required scientific data and document review.

Responsibilities Proven leadership experience in managing drug substance development teams at various experience levels internally (direct report mgmt.) and externally (CRO/CMO mgmt.)Manage multiple CMOs/CROs to deliver final bulk active drug substance (incl.

intermediates) of sufficient quality and quantity to meet corporate and regulatory requirementsCreate and disseminate technical transfer information and documents required by CROs/CMOs to develop and scale up chemical processes and develop analytical methodsEstablish and maintain business relationships with CROs and CMOs appropriate for performing process development requirementsCompose key terms for/review/execute contracts with, and manage the activities of, CROs/CMOs required to deliver process development tasks on time and within established budgetsMaintain in-depth knowledge of chemical steps, manufacturing processes, and quality controlsEnsure that CRO/CMO activities and other process development activities address drug substance needs for pharmaceutical formulation development, toxicology testing, clinical trials, and commercial launchEnsure that all chemical processes are developed to deliver on company targets of cost, quality, safety, environmental, and operability needsMaintain a working knowledge of manufacturers and suppliers of chemical raw materials, reagents, and intermediates capable of addressing the process requirements of the company in a timely and economical mannerIdentify and lead key process problem resolution activities and process improvement initiativesLead scale-up, process development, process engineering, and finalization (validation) of process for commercial-scale manufacturingExtract scientific data and provide appropriate document review to support regulatory filings and commercialization in a timely mannerCreate a culture of continuous improvement and high-performance teamworkContinually seek and implement process development best practice methodologiesWork closely with QA function to develop and operate to appropriate CMC procedures, and to ensure the product meets established quality standardsSupport authorship, review, and response to queries on all Module 3 drug substance development sections of CTD.

Expected to contribute to the overall regulatory strategy for the encaleret program (responsible for DS and consulted for DP strategy)Preference will be given to candidates with prior NDA/MAA authoring experience.

Prior NCE filing experience a plusUp to 20% travel may be requiredNo matter your role at BridgeBio, successful team members are:

Patient Champions, who put patients first and uphold strict ethical standardsEntrepreneurial Operators, who drive toward practical solutions and have an ownership mindsetTruth Seekers, who are detailed, rational, and humble problem solversIndividuals Who Inspire Excellence in themselves and those around themHigh-quality executors, who execute against goals and milestones with quality, precision, and speedEducation, Experience & Skills Requirements Minimum of Ph.

D. (ideally chemistry, chemical engineering) with 7+ years relevant experience, or BS/MS with 10+ years relevant experienceDemonstrated experience in managing API chemical development, process validation, and manufacturing in support of NDA marketing applications and commercial productionDemonstrated track record of delivering drug substance candidate(s) into chemical manufacturing and commercializationDemonstrated chemistry development at an industrial scaleSignificant project leadership experienceStrong aptitude and demonstrated experience in synthetic organic chemistryWorking knowledge of modern analytical separation techniques pertaining to the separation/purification of organic compoundsWorking knowledge of analytical methods development and validationFamiliarity with FDA and ICH guidelines for INDs/NDAs/MAAs and cGMPsThis position will also require a thorough understanding of cGMP, quality, and regulatory requirements, including the preparation and writing of key sections of regulatory documents (such as NDAs, MAAs, and INDs)

Experience in managing CMOs, scientific collaborations, and contracted R&DAbility to effectively interface with and/or manage highly skilled internal staffTraining and education in organic synthesisWorking knowledge of process economicsAbility to work independently as well as in a team; ability to build good work relationshipsStrong attention to detail and time management skillsExcellent oral and written communication skillsWhat We Offer Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our effortsA culture inspired by our values:

put patients first, think independently, be radically transparent, every minute counts, and let the science speakAn unyielding commitment to always putting patients first.

Learn more about how we do this hereA de-centralized model that enables our program teams to focus on advancing science and helping patients.

Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the scienceA place where you own the vision both for your program and your own career pathA collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our gameAccess to learning and development resources to help you get in the best professional shape of your lifeRobust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)Flexible PTORapid career advancement for strong performersPotential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over timeCommitment to Diversity, Equity & InclusionAt BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits.

Below is the anticipated salary range for candidates for this role who will work in California.

The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process.

BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.#J-18808-Ljbffr