Shire CMC Lead in Lexington, Massachusetts
Job Function and Description
Represents Technical Operations on early-stage product governance teams. Ensures delivery of CMC-related goals and facilitates communication between teams and stakeholders. (5% of time)
Leads early stage Technical Operations Product Team. Responsible to develop strategy to enable product development strategy for clinical programs and manage clinical supply, risk management, COGs management, regulatory activities, product / process Knowledge, and capability & improvement. (30% of time)
Leads Process Development and Technical Services Team through stages of clinical product development to biologics license filing. Responsible to plan and execute clinical product strategy, including process and assay development, characterization, technical transfer, process qualification, CMC filing documents, and support stability and shelf life for products. Responsible to represent product to agencies. (30% of time)
Ensure technical rigor of team deliverables and provides broad drug development oversight to the team. (35% of time)
Drive rigorous assessment of issues and options.
Ensure appropriate approval/endorsement of team recommendations and work streams.
Drives consensus and timely decision making.
Responsible for communication of project status and risks to governance bodies, line management, functional areas, and sub-teams.
Create a high functioning team, holding team members accountable for performance, and mentoring/coaching as needed.
Education and Experience Requirements
This individual will have a minimum of:
A PhD in Biochemistry, Protein Chemistry, Chemical Engineering or related disciplines with a minimum of 8 years of relevant experience in a biotechnology/pharmaceutical environment; or MS in Biochemistry or Chemical Engineering with a minimum of 10 years of experience is required;
Proven record of technical leadership
Proven record of cross-functional influence
Proven ability to work in a fast paced environment with demonstrated capacity to manage multiple tasks and demands.
Direct drug development experience
Experience with application of risk-based approaches in decision making
Experience in risk identification and management
Experience in process development and characterization leading to definition of design space
Experience in development and implementation of process control strategy using QbD principles
Key Skills, Abilities, and Competencies
Have excellent knowledge and experience with biologics process development and GMP manufacturing support, including cell culture, protein capture and recovery, chromatographic purification, filtration, UF/DF, and drug product formulation, etc.
Demonstrate teamwork/collaboration and the ability to communicate appropriately and effectively.
Be customer focused, results oriented, science driven and embrace Shire’s values.
This person will have technical leadership including the ability to influence, motivate, and drive technical rigor.
Candidate should have experience in healthcare/biotech/pharmaceutical industry with a demonstrated understanding of the interdependencies of research, technical development, GMP Manufacturing, Quality, Supply Chain, Preclinical, Clinical, Regulatory and Product Strategy functions.
Demonstrated leadership and capability for strategic analysis and issue resolution. Organizational skills working in a matrix environment.
Strong problem solving and risk based decision making skills and a strong ability to influence or manage without direct authority.
Highly developed interpersonal skills is a substantial component of being successful in this demanding role.
Complexity and Problem Solving
The individual will be expected to:
Assess and provide feedback to cross-functional technical proposals and recommendations.
Identify and analyze complex technical problems and then find and implement solutions.
Apply fundamental scientific and biological principles to practical technical challenges.
Manage multiple work streams and projects. Make sound and timely decisions based on project priorities.
Provide expert input to departmental and senior management towards making strategic and functional decisions.
Become the product and process subject matter expert within Tech Ops and Regulatory CMC.
Ensure CMC strategy development delivers on the following:
Ensure product for clinical studies
Ensure process and formulation improvement initiatives for products are planned implemented
Ensure CMC strategy to support regulatory filings for clinical trials and product launch
Ensure product and process knowledge is delivered per phase and implementation of QbD best practices
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.