Job: Associate Director/Principal Scientist, CMC Analytical Chemistry Location: San Francisco, CA or Thousand Oaks, CA Position type: Full Time Reports to: Director of Analytical Chemistry Organization Overview Latigo Bi…
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$190k–$220k/yr
Full-time
postgraduate degree, bachelor degree
Posted 11d ago
~40 hrs/week
Responsibilities
The Associate Director/Principal Scientist will manage analytical development activities from preclinical to clinical stages and oversee testing at contract manufacturers. They are responsible for method validation, stability programs, and authoring analytical sections for regulatory submissions.
Requirements
Candidates must hold a Ph.D. with 8+ years of experience or a BS/MS with 10-15 years of industry experience in analytical chemistry. Extensive knowledge of GLP/cGMP requirements and experience with small molecule analytical development are required.
Latigo Biotherapeutics is a public, clinical-stage biotechnology company discovering and developing the next generation of non-opioid medicines for pain and pain-related syndromes to transform the lives of patients. Latigo has a robust pipeline, is well-funded by blue chip investors, and has a highly successful management team and Board of Directors. The company was founded in 2019 and is based in Thousand Oaks, CA. We are science-based, data-driven, patient-focused, and forward-thinking.
Position Summary
Latigo is searching for an Associate Director/Principal Scientist, CMC Analytical Chemistry. Reporting to the Director of Analytical Chemistry, the candidate will manage preclinical to clinical analytical development activities and oversee the testing and release of drug substance and drug product at contract manufacturers/service providers. The role is responsible for the development, validation and implementation of QC methods for drug substance, drug product, intermediates, starting materials, excipients, and packaging materials at contract manufacturers.
Additional responsibilities include reference standard qualification and management, establishment of specifications, oversight of stability programs and the active management and documentation of data. The selected candidate will also work collaboratively with Quality Assurance to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to author Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.
Primary Responsibilities
Oversee the phase-appropriate analytical activity at contract manufacturers/service providers including analytical method development, qualification and validation for drug substance and drug product.
Partner with stakeholders to develop and set specifications for raw materials, intermediates, drug substance, excipients and drug product.
Design and manage stability programs for non-GMP and cGMP drug substance and drug product batches and provide guidance for shelf-life and expiry dating.
Establish workflows and procedures for analytical and quality control activities.
Manage reference standards program, coordinate sourcing, ensure inventory, plan and execute testing and retesting activities, and manage shipments of reference standards.
Author, review and approve various analytical reports in a timely manner to support drug substance and drug product development and manufacture, and regulatory filings.
Support regulatory submissions by drafting and reviewing analytical sections of INDs, IMPDs, and NDAs, and ensure compliance with current regulatory requirements.
Sometimes represent analytical function in CMC teams and project meetings, and work closely with cross-functional teams to meet project timelines and goals.
Review/approve controlled cGMP documents, e.g., analytical methods and associated validation protocols/reports, specifications, stability protocols, change controls, LIRs, etc.
Manage/perform QC review/approval of analytical test data for IPC testing, drug substance/product batch release and stability test data.
Manage and review deviation events and OOS/OOT investigations in coordination with CMC counterparts, QA and regulatory team members.
Contribute to the building of CMC infrastructure and company culture.
Qualifications and Requirements
Ph.D. with 8+ years of experience or BS or MS in chemistry or related discipline with 10-15 years of industry experience in an analytical chemistry setting.
Good understanding and knowledge of pharmaceutical analytical methods and related issues.
Experience with analytical development of small molecules and drug product oral dosage forms from preclinical to late-stage clinical development.
Experience managing drug substance and drug product service providers in analytical matters.
Extensive knowledge of GLP and cGMP requirements, appropriate regulatory guidance and current industry practices for analytical development.
Experience in writing CMC sections for Regulatory submissions (IND experience required; NDA experience highly desirable).
Excellent computer skills (e.g., Microsoft Office, Excel, Project).
Ability to effectively manage multiple priorities and projects.
Be able to work (hybrid) from Thousand Oaks or San Francisco, CA offices.
Positioned to change the treatment paradigm of pain medicines
Industry
Biotechnology Research
Company size
51-200 employees
Headquarters
Thousand Oaks, CA
LinkedIn followers
9,850
Total funding
$300M
Latigo Biotherapeutics (Nasdaq: LTGO) is a clinical-stage biopharmaceutical company committed to developing innovative non-opioid pain medicines designed to stop the transmission of pain without the risk of addiction, with the goal to provide effective, rapid-acting pain relief. Latigo’s lead product candidate, LTG-001, is an oral Nav1.8 inhibitor designed to provide fast-acting, opioid-sparing relief for the treatment of acute pain.
How many Healthcare jobs are open in San Francisco, CA right now?
There are currently 2,843 open healthcare positions in San Francisco, CA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in San Francisco, CA?
Companies currently hiring include UCSF Department of Anesthesia and Perioperative Care, Sutter Health, San Francisco Department of Public Health, One Medical, San Francisco Campus for Jewish Living, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in San Francisco, CA?
Yes — 848 of the 2843 open healthcare positions offer remote or hybrid work (194 remote, 654 hybrid).
How do I apply for Healthcare jobs in San Francisco, CA?
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