Scientist 1, QAT Analytical CMC

Who We Are
BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

TITLE

Sr. Associate or Scientist 1, QAT Analytical CMC

SUMMARY

The QAT Analytical CMC Senior Associate Scientist/Scientist 1 will collaborate with internal and external stakeholders to support BioMarin's clinical development and commercial manufacturing testing activities. Key activities including leading the development of control system strategies for new and existing products; supporting in-country test laboratories, leading the method lifecycle management, and authoring regulatory submission documentation.

RESPONSIBILITIES

Control System Strategy

Lead the development and implementation of phase-appropriate analytical control strategies, including test methods and specifications, in accordance with Critical Quality Attributes (CQAs). Ensure compliance with Health Authority (HA) and pharmacopeia requirements

Review methods and specifications, review of CQA reports from Process Sciences/MSAT for clinical products to assess the use of methodologies and specifications to ensure continuity and phase appropriateness

Oversee the control system strategy to ensure the implementation of market appropriate methods and specifications/controls; ensure that the method lifecycle control strategy considers "future proofing" the methods and validations to ensure compliance with all market requirements (Japan, Brazil, etc.)

Collaborate with key stakeholders in the review of proposed stability plans, data sets, etc. for filings to ensure consistency and; identify trends that drive method requirements and ensure methods are fit for purpose

Ensure reporting / filing is updated and accurate for any revisions to analytical methods made during the review interval requiring regulatory impact assessments

Complete the documentation of the summary of reportable changes to analytical methods

Method Lifecycle Management

Provide technical guidance, as subject matter experts to QAT Technical Laboratory Operations or QC Laboratories on the execution of method validation/transfer, DOE, Proof of concept study design, method lifecycle management, process comparability studies, forced degradation studies, process characterization, etc.; Design studies from other technical operations teams requiring CQA assessments, as applicable

Develop technical strategies to aid method lifecycle management activities, e.g., develop a library of impurities for products with input from MSAT and Process Science to identify the key impurities that require monitoring per product

Lead the development of plans to investigate and troubleshoot/optimize/replace underperforming methods, as required

Research new technologies for alternative testing or replacement of existing, aging or obsolete technology. Design proof of concept studies and work with executing analysts to manage these Proof-of-concept type studies, review output and draw conclusions to the proof-of-concept data and establish next steps

Conduct strategic assessments for any new product method transfers and validations and monitor the method development; draft master protocols and master reports for methods

Conduct strategic assessments for any new technologies, method optimization or single method introductions for existing products; review progress and review / approve any change requests, new protocols, and reports

CMC and Regulatory Support

Provide oversight on compliance of methods and specifications to Health Authority Industry and Pharmacopeia guidelines and requirements. Identify gaps and impacts when guidelines or pharmacopeia sections are updated

Author documentation summarizing reportable changes to analytical methods

Support the authoring and review of the CTD Module 3 DS and DP sections for INDs, IMPDs, BLAs, MAAs etc.

Author RTQs for methods and specifications and any other relevant sections; review responses from teams across QAT (standards/critical reagents, stability, and data) to ensure consistency, continuity

Work with Stability and Data Management team to factor in stability data for spec setting and relevant data analysis, etc.

Review batch analysis data tables, standards/critical reagents, stability, and data, etc., to ensure continuity across the team and documentation

Respond to queries related to analytical control system and method establishment during internal and external audits; direct interaction with regulatory agency inspectors during audit may be required

In-country test labs

Support the method transfer studies for In-Country (IC) testing laboratories and act as the point of contact for the IC laboratories through the entire licensing period.

Agree timelines, identify suitable transfer samples, draft master transfer protocol and report, review IC lab protocols and reports; Raise Change Request (CR) to capture IC lab introduction.

Coordinate supply of critical reagents and standards to In-country labs by working with critical reagent and Reference Standards team to ensure in-country lab has the required material to complete method transfer.

Cross-Functional Leadership

Act as the primary QAT point of contact for assigned product control system strategy and method lifecycle topics; represent QAT and the related control system strategy on the Quality Product Team

Support APR and AR activities

EXPERIENCE

@ Sr. Associate level: 5-8 years

@ Scientist 1 level : 8 years minimum

Required Skills:

Bachelor of Sciences degree in a technical discipline (physical, engineering, IT, chemical or biological sciences) is required,an MSc, or higher,in a relevant degree is preferred.

Minimum 5-8 years of relevant GMP laboratory experience, with hands on experience of analytical techniques.

Ability to understand the big picture and focus on execution details

Familiarity with the required deliverables for analytical method lifecycle activities, such as method validation, transfers, etc.

Proven track record in a fast-paced, challenging, and complex matrixed team environment

High degree of demonstrated learning agility

Action-oriented with strong follow through

Strong interpersonal skills; fluent and able to influence others in spoken and written English

Strong computer skills, MS Office, MS Word, MS PowerPoint, MS-Project is preferred

Highly developed interpersonal skills with the proven ability to function effectively and tactfully with multiple departments and personnel, able to gain consensus and commitment

Desired Skills:

Experience with CMC activities for development programs (Clinical stage)

Experience in early-stage clinical programs

Lean-DMAIC expertise, Green belt or higher certification.

Strong regulatory and GMP acumen.

EDUCATION

Bachelor of Sciences degree in a technical discipline (physical, engineering, IT, chemical or biological sciences) is required, an MSc, or higher, in a relevant degree is preferred. Qualification in Molecular Biology or Biochemistry is preferred.

EQUIPMENT

Standard office equipment

CONTACTS

QAT leadership team

QSAT Leadership Team

PQL Team

Regulatory affairs

SUPERVISOR RESPONSIBILITY

N/A

SHIFT DETAILS

Days Monday to Friday

ONSITE, REMOTE, OR FLEXIBLE

Flexible (minimum 2 days per week on site)

TRAVEL REQUIRED

Some travel may be required, less than once per quarter

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.