Senior Associate, Product Specification

Remote

Employer:

Description

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 nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An 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.

Who We Are

BioMarin 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.

In the U.S., the salary range for this position is $ 93,200 to $ 139,800 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.

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