Manufacturing Operations Technical Lead, CCP2
Diversity & Inclusion
Company: Genentech
Location: Vacaville
Posted on: February 22, 2021
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Job Description:
Manufacturing Operations Technical Lead, CCP2 This position is
accountable to be the Manufacturing Technical Lead for large-scale
capital projects as well as managing and ensuring alignment in
prioritizing the Manufacturing project portfolio in both CCP1 and
CCP2 The Manufacturing Operations Technical team lead is
responsible for coordinating user requirements, execution of
offline manufacturing review on the automated systems, coordinating
validation studies, being the manufacturing project interface (ie:
automation upgrade/capacity enhancements), enhancing the return to
service (RTS) program and execution of RTS activities, and ensuring
both plants are operationally ready for activities in compliance
with GMP requirements for both the CCP1 and CCP2 facilities. In
addition, the role is accountable for the strategic connection and
continuity across all strategic projects in Manufacturing to enable
successful project milestones. This role will be a representative
for Manufacturing in Vacaville site User Teams for capital
projects. This role will report into the head of CCP2 Manufacturing
and be a member of the Manufacturing Leadership Team (MLT). Job
Responsibilities Leadership & People Management: Provide oversight,
guidance, and direction to a cross-functional team that could
include site staff in the areas of Safety, Manufacturing,
Facilities & Engineering, MSAT, Materials Management, and Quality
regarding project objectives, user requirements, deliverables and
progress. Establish, sustain, and leverage effective partnerships
with network counterparts to share best practices and influence the
effective management of Manufacturing related projects Create an
environment of strong team spirit, timely and effective
communications, sense of urgency, high motivation and inspire teams
to achieve goals in the immediate and longer term Be an active and
visible change agent, promoting flexible and open mindsets to new
opportunities. Establish unified connectivity between
Manufacturing, asset management lifecycle, and investment
portfolio, to ensure instruments, equipment and machinery are able
to achieve long term objectives and obsolete equipment is replaced
before failure.-- Technical: Accountable for Manufacturing user
requirements being incorporated into project design to fulfill site
operational needs by gathering feedback and input from responsible
parties Develop goals and objectives in alignment with Project and
Tech Transfer Teams. Coordinate resolution of operational,
equipment or process issues related to design, construction,
commissioning, start-up or operation.-- Ensure project related
changes do not negatively impact CCP1/CCP2 licensed projects.
Interact with Facilities & Engineering and MSAT on manufacturing
process modifications required to enable production. Prepare and
present executive presentations and provide routine executive level
communication regarding project status updates to Manufacturing
leadership regarding; schedule progress, resource needs, budgetary
updates, and escalation of relevant issues. Coordinate, communicate
& provide leadership for the various RTS / issue resolution
sub-team leaders and help in routine and non-routine aspects for
the cross-functional leaders as related to their functional area(s)
work streams. Accountable to develop, coordinate and manage the
CCP1/CCP2 project portfolio including leadership of prioritization
of those activities. Close interaction with PTAA Project Manager
(PM) and PTAA Team, Tech Transfer Lead (TTL), and Site Transfer
Lead (STL), Project Management Excellence team on alignment and
execution of required Manufacturing User Requirements. Ensure that
any projects that impact Manufacturing (product technical
transfers, debottleneck projects, other) are aligned with
Genentech/Roche standards, and comply with applicable internal and
external Health Authority standards. Provide leadership and
oversight of CCP1/CCP2 systems startup, procedures and
documentation development Achieves operational objectives by
contributing information and recommendations to strategic plans and
reviews; preparing and completing action plans; implementing
production, productivity, quality, and customer-service standards;
resolving problems; completing audits; identifying trends;
determining system improvements; implementing change. Coordinate
with functional groups on production, operations, quality
assurance, testing, or maintenance requirements for Manufacturing.
Actively participate on the Manufacturing Leadership Team (MLT).
Report out project portfolio updates to Steering Committee monthly
Establish, sustain, and leverage effective partnerships with
network counterparts to share best practices and influence the
effective management of manufacturing related projects Meets
financial objectives by forecasting requirements; preparing
budgets; scheduling expenditures; analyzing variances; initiating
corrective actions. Analyze project portfolio resource demand and
coordinate with MLT to develop operational resource requirements--
Develop, review, approve, or modify Manufacturing project schedule
while coordinating with the site IMPACT/PACE portfolio process.
Confer with upper levels of management to set direction with the
required funding, resources, and schedules to meet required
delivery dates. Develop a sustainable process with the goal of real
time release of batches. Job Requirements Education: Bachelor's
Degree (life sciences or engineering preferred)-- Experience (may
vary depending on site size/scope) 12 or more years' related
professional experience or equivalent, ideally gained within the
biotech or pharmaceutical industry (manufacturing, engineering,
project and/or process management,).-- 8 or more years people
management experience (includes experience leading direct and
indirect reports)-- BA/BS in life sciences or engineering with
minimum 14 years project management experience including; budget
control, tracking, and forecasting; schedule oversight and
management; scope definition and control; change review tracking
and approval processes. Understanding of large-scale cGMP
manufacturing environments. Knowledge of quality standards for
manufacturing and change management at the site including thorough
understanding of Good Manufacturing Practices (GMP's) as they apply
to bioprocess manufacturing. Ability to effectively communicate to
all levels of the organization and across a broad cross-functional
audience. Strong understanding of and demonstrated experience with
cGMP requirements for biologics manufacturing Familiarity with the
execution of capital projects and project accounting is preferred
Strong familiarity with biologics manufacturing process
technologies. Experience with transfer and licensure of biologics
process is preferred Experience across a wide range of
pharmaceutical operations is strongly preferred-- Has successfully
led cross-functional teams-- Has effectively and efficiently
developed and implemented departmental annual or longer-range
strategies, plans and objectives; and successfully led staff
members in achievement of goals and objectives-- Consistently
presents strategic, complex and sometimes controversial information
and decision points to senior management in a highly effective,
efficient and fully successful manner-- Expert knowledge of cGMP
relevant to the pharmaceutical industry Expert knowledge with
start-up and validation of pharmaceutical manufacturing facilities
Possesses strong verbal and written communication skills and the
ability to influence at all levels. Capable at building trustful
and effective relationships Able to think strategically and
translate strategies into actionable plans Takes responsibility,
drives results, and achieves expected outcomes Ability to
effectively communicate to all levels of the organization and
across a broad cross-functional audience Who We Are Genentech, a
member of the Roche group and founder of the biotechnology
industry, is dedicated to pursuing groundbreaking science to
discover and develop medicines for people with serious and
life-threatening diseases. To solve the world's most complex health
challenges, we ask bigger questions that challenge our industry and
the boundaries of science to transform society. Our
transformational discoveries include the first targeted antibody
for cancer and the first medicine for primary progressive multiple
sclerosis. Diversity and Inclusion (D&I) are critical to the
success of our company and our impact on society. We believe that
by championing diversity of background, thought and experience, we
can foster a sense of belonging and provide an environment where
every employee feels valued, included, and able to contribute their
best for the patients we serve. We're focused on attracting,
retaining, developing and advancing our people to their full
potential by rewarding bold ways of thinking and integrating
inclusive behaviors into every aspect of our work. The next step is
yours. To apply today, click on the "Apply for this job" button.
Genentech is an equal opportunity employer & prohibits unlawful
discrimination based on race, color, religion, gender, sexual
orientation, gender identity/expression, national origin/ancestry,
age, disability, marital & veteran status. For more information
about equal employment opportunity, visit our Genentech Careers
page .
Keywords: Genentech, Vacaville , Manufacturing Operations Technical Lead, CCP2
Diversity & Inclusion, IT / Software / Systems , Vacaville, California
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