Septerna

Septerna

Senior Manager, Analytical Quality Control

South San Francisco, California, United States · Senior · Full-time

Sponsorship not specified$175k-$195kDetected 46 days ago
ComplianceSupply ChainPharmacologyGMPFDA RegulatoryResearchMass SpectrometryAnimal StudiesCommunicationCritical Thinking

About the role

  • This individual will leverage expertise in analytical data review and data trending to effectively manage stability studies, reference standards, and technical change controls.
  • We are seeking an experienced and highly motivated Senior Manager of Analytical Quality Control to manage analytical development and quality control activities on our small molecule programs with manufacturing and testing at Contract Development and Manufacturing Organizations (CDMOs).

Responsibilities

  • Provide QC oversight of analytical testing and stability studies performed at CDMOs for reference materials, drug substance, drug product, placebo, and finished goods and perform in-depth reviews of raw analytical data to ensure data integrity and compliance with specifications.
  • Establish and maintain processes for tracking and trending of CDMO testing against release and stability schedules.
  • Manage reference standards and reference materials including qualification, retest date and requalification, and inventory tracking.
  • Support development of and maintain compliance with the quality system to ensure product quality and data integrity, including authoring and reviewing standard operating procedures, guidelines, and work instructions.
  • Support the evaluation, selection, and management of CDMOs to perform reference standard management, GMP manufacture, release testing, and stability studies.
  • Collaborate cross functionally with teams including Analytical Development Process Chemistry, Pharmaceutical Development, Supply Chain Management, Quality, Regulatory, DMPK, Toxicology, and Clinical Pharmacology to achieve project goals.

Requirements

  • Demonstrated experience performing and managing analytical method development, phase appropriate method qualification/validation, and release and stability testing.
  • Knowledge of analytical techniques for small molecules and oral solid dose products.
  • Must be proficient in IR, UPLC/HPLC, KF, GC, dissolution, and microbial limit tests.
  • Experience applying compendial standards and regulatory authority guidance and expectations, including ICH, FDA, MHRA, and EMA guidelines and USP-NF, Ph.
  • Excellent interpersonal and communication skills (written and oral) with the ability to effectively and concisely present data to peers, management, and external groups.
  • Ability to travel domestically and internationally as needed, up to 10% of the time.
  • If you are a California resident, click here for our CCPA Notice.
  • A BS, MS, or PhD degree in analytical chemistry or related field with a minimum of 10 years, 8 years, or 5 years, respectively, of relevant industry experience with demonstrated increasing responsibilities within analytical quality control.
  • Demonstrated execution of QC activities supporting programs through clinical development.
  • Knowledge of analytical techniques for small molecules and oral solid dose products. Must be proficient in IR, UPLC/HPLC, KF, GC, dissolution, and microbial limit tests.
  • Proven proficiency working with quality systems including SOPs, protocols and reports, release and stability data review, OOT and OOS management, Good Documentation Practices, LIMS and cGMP data traceability, Deviations, and Change Management.
  • Experience applying compendial standards and regulatory authority guidance and expectations, including ICH, FDA, MHRA, and EMA guidelines and USP-NF, Ph. Eur, BP, and JP compendia.
  • Demonstrated experience managing and collaborating with external partners, including CDMOs.
  • Exhibited strong organizational and critical thinking skills with an attention to detail facilitating efficient data, document, and knowledge management across CMC.
  • Effective management of multiple priorities in a fast-paced environment.
  • The anticipated salary range for candidates who will work in South San Francisco, CA is $175,000 - $195,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.
  • We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Compensation

  • The anticipated salary range for candidates who will work in South San Francisco, CA is $175,000 - $195,000.

Benefits

  • We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.

Company info

  • Please do not forward any agency resumes.
  • The company will not be responsible for any fees related to resumes that are unsolicited.
  • Septerna participates in the E-Verify program.
  • We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients.
  • At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration.
  • We are committed to the development of meaningful therapeutics for patients with indications of high unmet need.
Apply directly at Septerna →Create a free account for alerts like thisView Septerna immigration profile

This listing is sourced directly from Septerna's careers page and normalized into a canonical job model.