External Manufacturing Associate Director (Person In Plant)
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: March 19, 2023
Job Description:
External Manufacturing Associate Director (Person In Plant) page
is loaded External Manufacturing Associate Director (Person In
Plant) Apply locations Boston, MA time type Full time posted on
Posted Yesterday job requisition id REQ-18425 Job DescriptionThe
primary focus of the Associate Director, External Manufacturing
role is to oversee operations of Vertex's external commercial
partner for the manufacture of small molecule Drug Product
utilizing a continuous manufacturing platform, working in the newly
formed External Manufacturing Operations team. The incumbent will
lead the internal Virtual Plant Team (VPT) that oversee 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 either at the Continuous
Manufacturing CDMO site(s) and/or be able to travel to those sites
routinely 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 Drug
Product (manufactured on our continuous manufacturing rig). 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. -Key Responsibilities:
- Acts as main point of contact for CDMO(s) including leader of
the CDMO VPT/working team and strategic business review
chairperson.
- Responsible for driving execution of the Trikafta DP production
plan: 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 eyes and ears to ensure flawless
execution of commercial operations. This may include some
off-hours/days to resolve urgent issues. -
- Lead continuous improvement initiatives to affect 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 CDMO's and to
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.
- Responsible for Long Term Strategic supplier management and
accountable for Supplier Relationship Management (SRM) and SRM
related processes for given CDMO.
- Leads identification and resolution of business/contract issues
(bring in legal, CMSC LT, Strategy+Bus Ops, Strategic
Sourcing).
- Partners with Global Supply Chain to develop 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. -Education and Experience:
- BS/BA degree in Biological Sciences, Chemical Engineering,
Chemistry or related discipline
- 8+ years of related experience of the equivalent combination of
education and experience with 5 years relevant experience in
biotech/pharmaceutical industry
- Understanding of the science and technology underlying Drug
Product 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 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 be able to build and sustain
organization respect and trust at all levels. -
- Problem solver with a hands-on approach and 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
practices. -
- Strong verbal and written communication skills: ability to
expresses oneself clearly and concisely, by adjusting style,
language and/or terminology as appropriate for the audience. -
- Flexibility to work shift hours required to cover critical
process steps and troubleshooting. -
- Ability to travel, national and international, up to
50%#LI-KO1#LI-RemoteCompany 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. Please note that Vertex requires
COVID-19 vaccination for all employees working in the U.S. as a
condition of employment at Vertex, subject to medical, religious or
other accommodations or exemptions required by law. We believe this
requirement is vital to keeping everyone at Vertex and in our
communities safe. This requirement applies to both existing and new
employees who may at any time work on-site at a Vertex facility or
visit another location on behalf of Vertex (e.g., conferences,
customer visits, etc.), including all remote employees. 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
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Ago About Us Help Us Achieve Our Mission Vertex is a global
biotechnology company that invests in scientific innovation to
create transformative medicines for people with serious diseases.
The company has multiple approved medicines that treat the
underlying cause of cystic fibrosis (CF) - a rare, life-threatening
genetic disease - and has several ongoing clinical and research
programs in CF. Beyond CF, Vertex has a robust pipeline of
investigational small molecule, cell and genetic therapies in other
serious diseases where it has deep insight into causal human
biology, including sickle cell disease, beta thalassemia,
APOL1-mediated kidney disease, pain, type 1 diabetes, alpha-1
antitrypsin deficiency and Duchenne muscular dystrophy.Founded in
1989 in Cambridge, Mass., Vertex's global headquarters is now
located in Boston's Innovation District and its international
headquarters is in London. Additionally, the company has research
and development sites and commercial offices in North America,
Europe, Australia and Latin America. Vertex is consistently
recognized as one of the industry's top places to work, including
13 consecutive years on Science magazine's Top Employers list and
one of Fortune's Best Workplaces in Biotechnology and
Pharmaceuticals and Best Workplaces for Women. For company updates
and to learn more about Vertex's history of innovation, visit
www.vrtx.com -or follow us on Facebook , - Twitter , - LinkedIn , -
YouTube -and - Instagram . The diversity and authenticity of our
people is part of what makes Vertex unique, and we recognize that
each employee brings diverse perspectives and strengths. By
embracing those strengths and celebrating differences, we are
fostering an inclusive culture where each of us can bring our
authentic selves to work, inspire innovation together, and change
people's lives. -Our vision is clear: to be the place where an
authentic, diverse mix of talent want to come, to stay, and do
their best work. ALERT: If you have signed up for Job Alerts,
please be aware that Job Alert Matches are currently not working.
During this time, please check our careers site regularly for all
open opportunities. We apologize for this systems issue and hope
for it to be resolved soon.
Keywords: Vertex Pharmaceuticals, Boston , External Manufacturing Associate Director (Person In Plant), Professions , Boston, Massachusetts
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