Associate Director, Analytical Sciences
- Management of outsourced and in-house research activities. Function as a subject matter expert for tech transfer/development of processes to external vendors (contract development and manufacturing organizations/contract testing organizations, CDMOs/CTOs). Create and execute plans for external projects by providing technical guidance, strategic and tactical direction, and oversight to ensure the product requirements are designed and delivered appropriately and in a timely manner for all stakeholders and customers across all stages of drug development, from discovery through preclinical to clinical and commercial.
- Independently lead and oversee analytical method development, validation, solid state characterization, release, and stability testing activities at CDMOs and in-house.
- Manage GMP manufacturing and product characterization activities at external partners, including preparation and review of analytical methods, Method Validation Protocols, Method Validation Reports, Stability protocols, and CoAs; work closely with process and formulation colleagues to propose/ justify specifications for RSMs, IPCs, intermediates, API, and DP based upon batch history data and control strategy.
- Manage and provide technical guidance during investigations/ quality events at CDMOs/ CTOs in collaboration with quality.
- Author and review technical reports, technical data packages, and relevant sections in health authority filings (including INDs, NDAs, annual reports, and any other regulatory interactions), and contribute to regulatory filing strategy.
- Prepare presentation materials and clearly communicate research results to manager, and at internal/external meetings.
- Work cross-functionally with Regulatory, Quality, Pre-clinical, Clinical supply, Process and Formulations Development colleagues.
- Maintain oversight of batch genealogy, stability, and test results to ensure all information is appropriately archived, readily available, and is transformed into useful knowledge and understanding.
- Work closely with formulation and process colleagues for CDMO selection, enablement and troubleshooting at site, and tech transfer. Proactively coordinate and work with CTOs, CDMOs, and CMOs ensuring smooth tech transfer, uninterrupted clinical supplies.
- Communication excellence in managing projects and deliverables, including budget planning, oversight in partnership with cross-functional colleagues, periodic organization and documentation of progress and accruals, and contract/PO/invoice coordination with finance.
- Ph.D. in analytical chemistry or relevant field with 10+ years of relevant hands-on pharmaceutical/biotech industry experience, or equivalent, in the field of new drug discovery and development.
- Demonstrated problem-solving skills, scientific curiosity, passion, critical thinking, and ability to quickly adapt and shift focus as needed.
- Demonstrated ability to take initiative, ownership, problem identification, problem solving and strategic input. A proven record of sustained laboratory achievement and innovation.
- Extensive hands-on experience and mechanistic understanding of analytical technologies including UHPLC, GC, LC-MS, GC-MS, SFC, dissolution, disintegration, wet chemistry, DSC, TGA, PSD, XRPD, spectroscopic and compendial methods.
- Awareness and knowledge of cross-functional activities such as toxicology and clinical development.
- Demonstrated ability to work independently and efficiently in a collaborative, fast-paced, integrated, multidisciplinary team environment that includes work internally and with external partners, such as research organizations/Universities, CTOs, CMOs, and CDMOs.
- Experience in writing and reviewing product specifications, method validation protocol/ reports, analytical methods, development reports, risk assessments, release, and stability.
- Experience in late-stage pharmaceutical drug development, such as discriminating dissolution method development, building control strategy, assembling data and authoring an NDA for a small molecule commercial product is highly preferred.
- Experience in process chemistry aspects of new drug development, including fate and purge studies, specification setting and justification, and other aspects required to building control strategy, assembling data and authoring an NDA for a small molecule commercial product is highly preferred.
- Working understanding of all ICH and regulatory guidances. A strong attention to detail and demonstrated prior experience working in lab, GLP, and cGMP environment.
- Scientific excellence as demonstrated by publications, presentations, and leadership/engagement in the scientific/professional community.
- Onsite, hybrid, or remote work are all negotiable.
Recommended Jobs
Hardware/Production Test Software Engineer
Astranis is on a mission to bridge the digital divide by connecting the four billion people worldwide who currently lack internet access. We're doing this by building the next generation of smaller, …
Dental Assistant Instructor
Job Description Job Description Teaching experience not required if you are an expert in the field. We will train! UEI College is a leader in post-secondary career education. Our mission is to …
Senior Key Accounts Manager
For 80 years, Murata Electronics has been a tireless innovator, committed to developing technologies that profoundly change the world around us. Our solutions are inside more state-of-the-art product…
Senior Accountant
We are seeking a hands-on, driven and experienced senior accountant with a track record of results in handling all the facets of accounting, month end close and financial reporting activities. The ca…
Senior Coordinator, Projects
Reporting to the Supervisor, Projects, this position will support the overall objectives of Joni and Friends’ Global Operations department. Perform duties and responsibilities including, but not limit…
Buyer (on-site)
Buyer (on-site) Location Valencia, CA : Lief Labs is a premier formulation and product development innovator and manufacturer of dietary supplements. Our in-house product development and R&D team cre…
Sales Coordinator 2 (Los Angeles)
A client of Innova Solutions is immediately hiring for a Sales Coordinator 2 Position type: Full Time, Contract Duration: 3months Location: Woodland Hills, CA (Remote) As a Sales Coordinator…
General Manager - Business Leader ( marketing, NPD, full P&L leadership focused ) REMOTE
As GM, you’ll lead our wellness products—owning the brand’s P&L, growth roadmap, innovation pipeline, and team. You’ll set the strategy and roll up your sleeves to make it real. From revitalizing our…
Millwright (433A, Injection Molding)
Job description: Perform predictive and preventative maintenance on plastic extrusion machinery, manufacturing equipment, and machine shop tools to ensure optimal performance and longevity. …
Plant Manager I (Fresno, CA)
Job Description Job Description Company Description Foster Farms has been serving families since 1939. Since the founding days, Foster Farms has always been committed to providing consumers …