Associate Director, Analytical Development - Biologics

MISSIONMirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.

POSITION SUMMARYWe are looking for an Associate Director of Analytical Development – Biologics who is organized, self-motivated, collaborative, detail-oriented, has a strong analytical background and knowledge base.  The person filling this role will partner with the Executive Director of Analytical Development/QC – Biologics to execute and support method development and validation, technology transfer, method lifecycle management, ensuring that methods are scientifically sound, robust, fit for purpose and compliant with applicable regulatory requirements.

This role requires a pragmatic hands-on scientist who exercises scientific judgement and proactively identifies and resolves technical challenges to meet program milestones. This position is located in Foster City.

JOB FUNCTIONS/RESPONSIBILITIES Serve as a key member of cross-functional CMC teams comprising Quality, Manufacturing, and Regulatory representatives

Lead and support method transfer activities between external sending and receiving laboratories

Review analytical method validation and transfer protocols and reports

Provide technical support to receiving laboratories on analytical procedures and instrumentation as required and to ensure successful transfer

Ensure transferred methods meet predefined acceptance criteria and are suitable for routine GMP testing

Support risk assessments, gap assessments, and method comparability evaluations in support of method transfer

Support analytical method related and product trending activities

Oversee reference standard and critical reagent qualification and inventory management

Record and report analytical results accurately in worksheets, logbooks, LIMS, or electronic systems

Review analytical data for accuracy, completeness, and compliance with GMP and data integrity requirements

Record and report analytical results accurately in LIMS, or electronic systems

Work with QC and QA to support investigations related to OOS, OOT and OOE, deviations and laboratory incidents

Follow company SOPs, pharmacopoeia methods, and regulatory guidelines, e.g. USP, EP, ICH, and FDA/EMA requirementsQUALIFICATIONSEducation /

Experience:

BS/MS in Biochemistry, Chemistry, or a Biological Science with 8+ years of industry experience in biologics pharmaceutical manufacturing and testing

Hands-on experience with analytical instruments, especially CE, HPLC, UV, and LC-MS for biological compounds

Knowledge of GXPKNOWLEDGE, SKILLS, AND ABILITIES Strong interpersonal skills and ability to collaborate across functions

Ability to respond effectively to changing priorities, evolving program needs, and unexpected technical challenges

Experience with technology transfer to multiple locations and countries for clinical and late phase product testing

Ability to investigate and troubleshoot analytical issues

Ability to work under deadlines and manage multiple projects

Experience with stability testing and analytical method transfer/validation.

Strong attention to detail and accuracy

Excellent analytical skills and data management skills

Good documentation and report-writing skills.

Excellent communication skills for both written and verbal presentations

Track record in authoring and reviewing of regulatory documentation (e.g. INDs, IMPD, MAAs, BLAs)
The salary range for this position is $190,000 to $210,000

USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.#LI-HYBRIDMirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other…