Who We Are Bio Marin
Bio Marin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need.
We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science.
With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
Bio Marin'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 Bio Marin'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.
Scientist 2, Technical Development & Services (Hybrid - Shanbally, Cork)
Closing Date: February 28th, 2025
Summary: The AS APL Scientist 2 will collaborate with internal and external stakeholders to support Bio Marin'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.
The APL Scientist will provide oversight, understanding and management of product attributes and analytical control strategy.
Ensuring all aspects of analytical methods as part of analytical control strategy are suitable for their intended use and meet the Analytical and Quality Target Product Profile (ATTP/QTPP).
Analytical Sciences contacts facing CMC, Quality Partner teams and other stakeholders.
Responsibilities
* Accountable for phase appropriate method qualification, method optimization, method transfer and method validation strategies through all phases (including raw material methods not currently established at QC)
* Accountable for test method selection (strategy) and CTO selection
* Responsible for method life cycle management support
* Accountable for locating AS resources for testing support for process development, in-use studies, formulation development studies, scale-up/yield studies, external lab testing, characterization and forced degradation.
Product Understanding and Control Strategy
* Accountable and responsible for CQA assessment through all phases
* Accountable (prior to PPQ) and responsible (after PPQ) for analytical control strategy
* Accountable (prior to PPQ) and responsible (after PPQ) for sampling & testing plans aligned with analytical control strategy
* Accountable for product characterization strategy
* Lead the development and implementation of phase-appropriate analytical control strategies, including test methods and specifications, in accordance with Critical Quality Attributes (CQAs).
Regulatory
* 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;
* 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
QMS
* Responsible for technical assessments of QMS records as required (Deviation, CAPA, Change Controls)
* For technical assessment of analytical method or specification impacting records
Cross-Functional Leadership
* Act as the primary AS single point of contact for assigned product programs;
* Represent AS and the related control system strategy on the Quality Product Team
Experience:
* 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 10 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
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:
* ASPL leadership team
* AS and TDS Leadership Teams
* PQL Team Regulatory affairs Supervisor
Responsibilities:
N/A
Shift Details:
* Days - Monday to Friday Flexible (minimum 2 days per week on site)
* Some travel may be required, less than once per quarter
Note:
* This description is not intended to be all-inclusive, or a limitation of the duties of the position.
* It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer:
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.