Director, Analytical Development & Quality Control

Location
Menlo Park, CA
Posted
May 03, 2021
Ref
CMC-1002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

AN2 Therapeutics (AN2) is a biopharmaceutical company focused on developing novel medicines for patients with rare, orphan infectious diseases that represent significant unmet needs. Founded by a team of experienced industry leaders in infectious disease drug research and development, we strive to provide patients with treatments that will restore their health and enable them to live productive lives. AN2 is a mission-driven company with a passion for improving global public health and a vision to accelerate development of novel medicines to treat serious infectious diseases and save lives worldwide. We believe our company thrives when all employees share this mission.

AN2 is seeking an experienced Director of Analytical Development & Quality Control to support development of its investigational drug programs. The individual will play an essential role in cross-functional teams and will be responsible for driving CMC activities related to analytical development for both API and drug products. This position will report to the Vice President of Drug Manufacturing Development & CMC. This is not a lab position.

 

Responsibilities

  • Ensures all analytical development & stability activities for both drug substance and drug product are aligned with AN2’s project goals and timelines.

  • Works collaboratively with internal stakeholder functions such as Project Management, Clinical, and Regulatory to meet program goals. Represents CMC on development teams. Coordinates seamlessly with CMC colleagues overseeing drug substance and drug product activities.

  • Manages all analytical development related activities at external vendors, including oversight of method development & validation, and stability programs.

  • Reviews all analytical related technical documents, including method development reports, method validation protocols & reports, test methods, and specifications.

  • Takes an active role and applies subject matter expertise in establishing phase-appropriate analytical methods & validation, and release & shelf-life specifications.

  • Implements Quality by Design (QbD) and applies risk-based principles to establish the Quality Target Product Profile and required Critical Quality Attributes & Critical Material Attributes.

  • Oversees qualification of reference materials and management of their inventory & supply across testing sites.

  • Review and QC of batch record analytical data packages; provides technical input toward batch release.

  • Oversees CMO analytical deviation & event investigations, and resolution of out‑of‑specification (OOS) and out‑of‑trend (OOT) testing results.

  • Manages stability programs including protocol design and specifications, and data review, trending, and analysis. Ensures stability studies support clinical development and regulatory objectives & timelines.

  • Ensures that all work is conducted in accordance with applicable policies and procedures, CGMP, and regulatory standards & guidelines. Maintains an understanding of global laws & regulations applicable to the pharmaceutical industry.

  • Prepares pharmaceutical development reports and other technical documentation required for regulatory submissions including authoring, review, and approval of the requisite sections of IND, CTA, IMPD, NDA, MAA or other filings.

  • Assists in the responses to health authority questions.

  • Leads and participates in initiatives for improving functional processes and technical operations within CMC.

  • Participates in technical audits during vendor selection.

  • Functions as person-in-plant as needed during manufacturing campaigns.

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    Qualifications and Experience

  • MS or BS in Analytical Chemistry or related discipline with at least 10 years of experience working in CMC development in the pharmaceutical industry; or equivalent.

  • Expert in a wide variety of analytical methodology and instrumentation used in the testing and characterization of raw materials, excipients, drug substances, and drug products.

  • Significant or majority of experience amassed in support of small-molecule NCE drugs and their solid oral dosage forms.

  • Successful leadership of analytical method development & validation, production QC, and stability program activities.

  • Expert in impurity/degradant identification and coordinating qualification with non-clinical colleagues.

  • Demonstrated experience driving these CMC activities in a virtual pharma business setting through management of external partners and CRO/CMOs.

  • Capability to manage budgets, prepare RFPs, review and approve work orders, and liaise with legal and quality departments for MSA and QTA agreements.

  • Experienced in production/testing site audits and collaboration with QA representatives for site selection and qualification.

  • Excellent awareness & understanding of other stakeholder roles in CMC, and analytical development's relationship to them.

  • Excellent working knowledge of CGMP, regulatory guidance, and compendial requirements, including FDA, EMA, ICH, WHO, USP-NF and EP.

  • Demonstrable experience as a primary author of CMC sections in regulatory filings, such as IND, IMPD, and NDA.

  • Excellent technical writing, oral, presentation, and interpersonal communication skills.

  • Excellent data presentation & analysis skills, including the creation of publication quality tables & graphs.

  • Fluent in the Microsoft ecosystem, including Office & SharePoint, and PDF publication & editing software such as Adobe Acrobat. Comfortable with electronic records & digital workflows.

  • Fastidiously detail-oriented and organized; impeccable attention to data QC.

  • Possesses high integrity and exceptional work ethic.

  • Must be flexible and able to multitask, prioritize, meet deadlines in a fast paced environment, and be adaptable to setbacks. Exceptional problem-solving skills.

  • Team oriented; ability to work collaboratively with internal colleagues and vendors.

  • Understands and anticipates the impact of business and commercial needs on advanced-stage drug development. Distinguishes research from development.

  • Some travel required, including both domestic and international (10-20%).

  • We are an equal opportunity employer that values diversity, equity, and inclusion. We consider all qualified applicants regardless of race, sex, gender identity or expression, sexual orientation, age, religion, national origin, marital status, veteran status, or ability status. We will ensure that individuals who are differently abled are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment as provided to other applicants or employees. Please contact us to request accommodation.

    Our open positions are managed through our Human Resources department. Unsolicited resumes from recruiting agencies, in advance of a specified agreement, will not be accepted. Resumes sent directly to our employees or our consultants from recruiting organizations will also not be accepted as referrals and do not obligate us to pay fees.

    Please send your resume and include the job title and number in the subject.

    Job Reference Number: CMC-1002

    * AN2 Therapeutics is based in Menlo Park, CA, but employees are currently working remotely due to the COVID-19 pandemic.