Job description Site Name: USA - Massachusetts - Waltham
Posted Date: Aug 24 2020
GSK is growing the Waltham, MA based Strategic External
Development (SED) enterprise to deliver on our portfolio of
transformative medicines to patients around the world. The
externally focused SED enterprise will be an empowered, innovative
and agile CMC development organization that will unlock the
potential to rapidly deliver an increased number of transformative
medicines to patients through exceptional relationships with
trusted global partners.
The Strategic External Development enterprise has been built
from the foundation of the legacy TESARO CMC development
organization and has the responsibility of harnessing the global
development and manufacturing capabilities of strategic
partnerships and relationships to accelerate the availability of
GSK’s pipeline of transformative medicines for patients.
With an exciting project pipeline, an amazing team, partners at
the ready, we are looking for a Process Engineering Leader who will
play a critical role in developing and registering the company’s
pipeline of development-stage biologics candidates.
This role will provide YOU the opportunity to lead key
activities to progress YOUR career, these responsibilities include
some of the following:
Lead technology transfer of biologics manufacturing processing
as part of a cross-functional team to internal nodes and/or
external contract manufacturing organizations
Lead the effort in establishing a comprehensive biologics drug
substance process performance qualification (PPQ) strategy for
Responsible for establishing an integrated biologics drug
substance process control strategy including developing
capabilities are strategic partners and ensure smooth transition to
the Strategic External Manufacturing group at the commercial
Author, review and/or approve PPQ protocols and PPQ reports by
collaborating with quality, regulatory and external CDMO business
Manage and oversee PPQ related activities at CDMO sites in close
collaboration with Quality Assurance
Collaborate with regulatory-CMC in defining technical content,
related to drug substance, of module 3 for BLA/MAA submission and
ensure submission timelines are met.
Author and review responses to regulatory inquiry regarding BLA
and MAA filings.
Responsible for meeting PMCs and/or PMRs.
Lead effort in defining strategy for product life cycle
management including continuous improvement efforts and global
market authorization strategy
Keep abreast of the evolving global regulatory requirements and
industry standard practices for biologics drug substance PPQ and
BLA/MAA submission and approval.
Collaborate with internal stakeholders and external business
partners to achieve group, departmental and corporate goals.
Partner effectively and transparently with internal stakeholders
in the areas of Biologics Operations, Analytical Development,
Biologics Drug Product Development, CMC Project Management, Quality
Assurance and Quality Control, Regulatory Affairs, and Commercial
Manufacturing and external CDMO business partners
Ph.D./MS in chemical/biochemical engineering, chemistry,
biology, biochemistry, or related technical discipline.
Minimum of 12 years of biologics drug substance development
Demonstrated track record of leading and managing late stage
biologics drug substance process development, process
characterization, process performance qualification activities.
Hands-on working experience in BLA/MAA drafting, submission and
Hands-on working experience in biologics product life cycle
Strong knowledge of CMC regulatory requirements from IND filing
to BLA/MAA submission and approval.
Demonstrated track record of CDMO management in supporting
manufacturing process development and GMP manufacturing.
Ability to work in a fast-paced, multi-disciplinary environment
with potential for rapidly changing priorities.
Strong communication skills: ability to communicate (verbally
and in writing) technical and non-technical information clearly to
a diverse audience.
Self-motivated, with the ability to act with urgency and
Proven ability to work with at a high level of integrity,
accuracy, and attention to detail.
Ability to make thoughtful, integrated, timely and meaningful
recommendations and/or decisions and take corresponding
Resourceful, enthusiastic, innovative and results-oriented.
Ability to work under pressure, meeting time sensitive
deadlines, while maintaining a high level of confidentiality.
Our values and expectations are at the heart of everything we do
and form an important part of our culture. These include Patient
focus, Transparency, Respect, Integrity along with Courage,
Accountability, Development, and Teamwork. As GSK focuses on our
values and expectations and a culture of innovation, performance,
and trust, the successful candidate will demonstrate the following
Agile and distributed decision-making – using evidence and
applying judgement to balance pace, rigour and risk, governance and
control, managing ambiguity and paradox.
Managing individual performance.
Creating a performance culture and driving results,
prioritisation, execution, delivering performance.
Setting strategic direction and leading on-going organisational
Building a resilient organisation. Building strong relationships
and collaboration in service of common goals, engaging the
organisation and building trusted external networks for mutual
Managing P&L and capital allocation
If you require an accommodation or other assistance to apply for
a job at GSK, please contact the GSK Service Centre at
1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere
to Affirmative Action principles. This ensures that all qualified
applicants will receive equal consideration for employment without
regard to race, color, national origin, religion, sex, pregnancy,
marital status, sexual orientation, gender identity/expression,
age, disability, genetic information, military service,
covered/protected veteran status or any other federal, state or
local protected class.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or
employment agencies in respect of the vacancies posted on this
site. All employment businesses/agencies are required to contact
GSK's commercial and general procurement/human resources department
to obtain prior written authorization before referring any
candidates to GSK. The obtaining of prior written authorization is
a condition precedent to any agreement (verbal or written) between
the employment business/ agency and GSK. In the absence of such
written authorization being obtained any actions undertaken by the
employment business/agency shall be deemed to have been performed
without the consent or contractual agreement of GSK. GSK shall
therefore not be liable for any fees arising from such actions or
any fees arising from any referrals by employment
businesses/agencies in respect of the vacancies posted on this
Please note that if you are a US Licensed Healthcare
Professional or Healthcare Professional as defined by the laws of
the state issuing your license, GSK may be required to capture and
report expenses GSK incurs, on your behalf, in the event you are
afforded an interview for employment. This capture of applicable
transfers of value is necessary to ensure GSK’s compliance to all
federal and state US Transparency requirements. For more
information, please visit GSK’s Transparency Reporting For the
Full-Time, Waltham, Massachusetts, United States Director,
Biologics Process Engineering Full-Time, Waltham, Massachusetts,
United States Start a career with purpose GSK is a place where
outstanding people do amazing things. As a science-led global
healthcare company, we exist to help people do more, feel better,
Annual bonus based on company performance
Long term incentives and pension plan
Learning and career development
Access to healthcare & wellbeing programmes