External Manufacturing Senior Manager, Finished Goods (Person In Plant) - REMOTE ELIGIBLE
Semma Therapeutics
Job Description
External Manufacturing Sr. Manager, Person in Plant (Finished Goods)
The primary focus of the Sr. Manager role is to oversee operations of Vertex’s external US commercial partner(s) for the manufacture of small molecule finished goods products. The incumbent will lead the internal virtual plant team that oversees the operations at the CDMO and co-lead joint project teams with the CDMO, while contributing to the broader External Manufacturing group activities. The candidate will be located close to the US CDMO site(s) outside of Philadelphia, PA and/or be able to travel to those sites 3 days/week as a “Person-in-Plant”.
Managing the external manufacturing network is a critical component of the Commercial Manufacturing and Supply Chain team’s role in ensuring that the company effectively and efficiently delivers medicines to patients. As such, we are looking for a leader to provide vision, leadership, and both strategic and enterprise thinking in the management of the external partner. The candidate should have broad professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of finished goods. The Sr. Manager will provide vision, leadership, and strategic thinking in the management of the external partners. This leader will also cultivate and leverage multiple cross-functional business relationships to identify and execute creative solutions to organizational opportunities and challenges.
The Sr. Manager will report directly to the Director, External Manufacturing Operations. This leader should have a strong operational, quality, compliance, and technical background, with proven project management and supplier management abilities. They should have the ability to cultivate and leverage multiple cross-functional business relationships to identify and execute creative solutions to organizational opportunities and challenges.
The candidate will be in a remote role, with travel to CMO sites routinely as a “Person-in-Plant”. This role will be accountable for all Finished Goods external commercial manufacturing operations activities in the US for small molecules. This role will partner closely with colleagues across Vertex to ensure a seamless supply of all Finished Goods commercial products.
Key Responsibilities:
- Acts as the main point of contact for CDMO(s) including the leader of the CDMO VPT/working team.
- Responsible for driving execution of commercial and late stage/launch production plans: provide operational oversight, and troubleshooting support, to ensure all deliverables meet or exceed Vertex requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance, and cost management).
- Maintain on-site presence acting as the Person-in-Plant at the CDMO facility and be Vertex’s first point of contact to ensure flawless execution of commercial operations. This may include some off-hours/days to resolve urgent issues.
- Lead continuous improvement initiatives to affect the timely resolution of supply issues.
- Build and maintain strategic relationships within the CDMO organization as well as key internal stakeholders.
- Partners with Tech Ops, Quality, and CMSC Strategy and Business Operations champion a culture of quality with our CDMOs and ensure that all activities and documentation comply with regulatory requirements.
- Monitor CMO performance using a set of standard KPIs (Key Performance Indicators) and report progress to management.
- Supports identification and resolution of business/contract issues (bring in legal, CMSC LT, Strategy+Bus Ops, Strategic Sourcing).
- Partners with Global Supply Chain to develop a long-term manufacturing network strategy and to maintain a flexible, reliable, robust, and cost-effective manufacturing network.
- Champions a strong winning culture, fostering teamwork and commitment to excellence through transparent communication and staff engagement.
Minimal Requirements:
- 8+ years of progressive experience in a leadership/management role in pharmaceutical development and commercial manufacturing
- Understanding of the science and technology underlying Finished Goods manufacturing as well as analytical techniques that support commercial manufacturing activities
- Demonstrated understanding of the principles and applications associated with commercial manufacturing operations, maintenance, and engineering
- Strong knowledge of cGMP requirements
- A strategic thinker with a strong result orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
- Understanding of the technical aspects of manufacturing, testing, and controls, the regulations governing pharmaceutical operations, as well as financial systems and controls
- Excellent communication and interpersonal skills with the ability to work in strong cross-functional relationships and communicate complex issues and concepts enterprise-wide, from the executive team to the manufacturing floor
- Excellent team player and able to build and sustain organizational respect and trust at all levels
- Problem solver with a hands-on approach and the ability to anticipate adverse scenarios and provide contingency plans to address them
- Resilient and able to work well in a demanding, fast-paced entrepreneurial environment
- Sound judgment and business acumen with personal versatility and flexibility as business and team evolve
- Keeps current on professional knowledge, expertise, and best practice.
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Salary range: $132,800 - $199,200 annually
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.