Jobs and Careers

Senior Associate, Product Specification

United States, United Statesfull_timeVerifiedPosted 5 Dec 2024

About the role

About Technical Operations

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.

Senior Associate, Product Specification Role Overview The Product Specification Senior Associate is a critical role within BioMarin’s Product Quality Lifecycle Management organization, responsible for the management and maintenance of product specifications throughout the product lifecycle. This individual will ensure that all specifications, including those for reference standards, intermediates, drug substances, and drug products, are accurate, compliant, and aligned with regulatory requirements. This position will collaborate cross-functionally to ensure accurate and consistent product documentation, enabling efficient product release, regulatory compliance, and product lifecycle management. The role requires a strong focus on quality, attention to detail and proactive problem-solving to address specifications-related challenges and maintain compliance with evolving regulatory requirements. This position will play a vital role in ensuring the quality and compliance of BioMarin’s innovative life-saving products, supporting their successful development, commercialization, and lifecycle management. Key Responsibilities

Responsible for the product specification document lifecycle: establishes, maintains and retires product specifications for reference standards, intermediates, drug substances, and drug products.
Owner and/or approver of change control records for product specification documents in the QMS.
Works closely and effectively with other team members, demonstrating strong teamwork, communication, and interpersonal skills to achieve departmental goals.
Collaborates and builds effective relationships across multiple levels in Quality, Technical Development Services, Supply Chain, and Regulatory Affairs.
Serves as impact assessor for change controls, evaluating proposed changes and identifying their impact on product specifications documents and related processes.
Assists with managing specification-related deviations by helping to investigate root causes, working closely with cross-functional teams to support the implementation of corrective and preventive actions, and contributing to timely resolution in compliance with quality and regulatory standards.
Tracks and reports key performance metrics related to specification management (e.g., timeliness of updates), ensuring alignment with organizational goals and identifying opportunities for continuous improvement.
Participates in process improvement initiatives to enhance the efficiency, accuracy, and compliance of specification management systems and workflows. Partners with cross-functional teams to identify opportunities for streamlining specification-related processes and implement solutions.
Responsible to support the maintenance and updates function-specific guidelines and SOPs.
Supports regulatory inspections and internal audits, providing necessary documentation and expertise.
Authors other technical documents, such as manual CofAs, as needed.

Experience/Education

BA/BS in life sciences or related field required.

3+ years of experience in product specification management, technical writing, or related roles in the Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry.
Strong understanding of cGMPs principles, concepts, practices and standards.

Excellent organizational skills, with attention to detail.

Proven ability to manage multiple projects and meet deadlines in a fast-paced environment.
Excellent written and verbal skills; collaborative mindset with the ability to communicate and work effectively across functions.

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 n