Myovant Sciences is a biopharmaceutical startup company focused on delivering innovative women’s health and prostate cancer solutions. We are currently seeking a qualified, highly motivated, experienced individual to join our fast growing team for the position of Director/Associate Director, Contract Manufacturing. The position reports to the Vice President, Pharmaceutical Operations & Development (POD). The location of the position is in the South San Francisco area.
This position is responsible for selection and manage of all external manufacturing sites to ensure quality, compliance and efficiency in meeting project needs and production requirements; collaborates with leadership and partners in defining matrix/process for selection of clinical and commercial manufacturing sites for Relugolix and other portfolio compounds, forecasting and managing development and production schedules, establishing technical transfer strategies and tactics and project milestones. Manage day-to-day operations and communications with internal partners and contract manufacturing sites to ensure effective delivery of product supplies to meet project needs. Build effective and strategic partnership with CMOs to meet Myovant business needs. Forecast, prepare and monitor budget for external manufacturing, and manage project timelines. Manage and drive cross-functional relationships required to provide high quality, cost-effective production and material. Participate in planning and execution of Myovant CMC strategies and become a member of PDM leadership team.
The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
Essential Duties & Responsibilities
- Manage CMOs to meet the commercial demands (supply & timeline), and lead cross functional team internal/external to resolve unplanned issue.
- Lead and coordinate the overall evaluation and selection of external contract development & manufacturing organizations (CDMOs) for clinical and commercial needs.
- Serves as the point of contact for Contract Development & Manufacturing Organizations (CDMOs), and act as a business relationship manager.
- Actively manages contract manufacturers (CMOs) in assigned projects to coordinate technology transfer and development efforts per project milestones, timelines, and deliverables for projects, organizing project team meetings and steering committees and driving accountability.
- Reviews and coordinate RFPs (request for proposals),
- Challenges proposals received from CMOs/CROs.
- Places orders for custom manufactured materials, active pharmaceutical ingredients (APIs), bulk drug products and packaging components.
- Coordinates release and stability tests for supplies, and shipping samples to various CROs as needed.
- Monitors material shipments from global CMOs, resolves any related shipment issues
- Investigates and resolves inventory / order discrepancies in a timely manner, follows up on invoicing and ensures on time payment as needed.
- Monitors and verifies implementation of Myovant’s controlled documents at CDMOs partner sites.
- Coordinates meetings, participate in teleconferences and face to face meetings with CMOs/CROs, publishes agenda and meeting minutes. Leads the meetings.
- Assist in review and revision of departmental SOPs in order to streamline and improve current practices.
- Manages CMOs on a daily basis, responsible for all interactions with CMO’s on the assigned projects.
- Works with line manager and partner functions to develop processes/systems to effectively manage vendor selection and performance assessments.
- Participates in solving issues of high complexity and generation of COGs.
- Communicates issues to line manager and project team in a timely manner.
- Develops specific manufacturing recommendations for coordination of production schedules, environmental concerns, and safety issues.
- Coordinates production flow from Process Development to Manufacturing.
- Supervises and monitors performance of Manufacturing Managers and Team Leaders. Coordinates production schedules based on sales and/or clinical requirements.
- Responsible for driving continuous improvement in all operation processes
- Perform other duties as assigned.
Qualification and Requirements
- 15+ years of progressive experience in the pharmaceutical contract manufacturing management and a BS or BA. 12+ years of relevant experience and a MS.
- Good understanding of the CMO landscape, knowledge of CMO capabilities and limitations
- Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs)
- Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards.
- Demonstrates strong computer, organizational, and management skills.
- Solid knowledge of regulatory requirements in the US and the EU.
- Excellent verbal, written and interpersonal communication skills.
- Has proven successful experience developing and monitoring budgets and expenditures.
- Has proven successful experience in a cross-functional project team
- Has proven successful experience with manufacturing administration or similar.
- Has proven successful track record of establishing effective relationship with internal and external stakeholders to achieve on time, cost-effective delivery of quality products
- Experience in CMC technical development is preferred.
- Project management experience and/or certification is a plus.
Essential Core Competencies
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
- Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
- Daily demonstrates a positive, ‘can do’ and service oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
- Ability to multi-task and shift priorities quickly while working under tight deadlines.
- Skilled in developing collaborative internal and external relationships.
- Required skill in the operation of standard office equipment including: fax machines, copy machines and other equipment as necessary.
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Communication & Interpersonal Skills
- Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders and employees.
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Domestic or international travel will be required per business needs
- Regularly required to operate standard office equipment
- Ability to work on a computer for extended periods of time
- Regularly required to sit for long periods of time, and occasionally stand and walk
- Regularly required to use hands to operate computer and other office equipment
- Close vision required for computer usage
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Equal Employment Opportunity