Vice President of Manufacturing
Company: Agcbio
Location: Seattle
Posted on: May 26, 2023
Job Description:
AGC Biologics is a leading global Contract Development and
Manufacturing Organization, with a deep commitment to improving
life quality by bringing new biopharmaceuticals to market. Because
of our dedication to building and empowering our internal teams,
AGC Biologics is an innovative leader in the industry with an
extensive network of cGMP facilities in the US, Europe and Asia. As
such, we deliver a deep expertise, dynamic solutions and
technologies, as well as customized services for the scale-up and
cGMP manufacturing of protein-based therapeutics and cell and gene
therapies. We forge exceptionally strong partnerships with our
clients, and we never lose sight of our pledge to deliver a
reliable and compliant drug substance supply, Right, On time. For
more information, visit .
SUMMARY:
The Vice President, Manufacturing will oversee and direct the
strategy and execution of AGC Biologics' 24/7 manufacturing
operations at the Bothell site for pre-clinical, clinical, and
commercial supply of therapeutic proteins that treat serious
medical conditions. Functional areas within manufacturing include:
Upstream Operations, Downstream Operations, Final Fill Bulk Drug
Substance, Support, Strategic Operations, and Compliance. This role
reports to the General Manager of AGC Biologics Bothell Site.
PRINCIPAL RESPONSIBILITIES:
- Responsible for the development, implementation, oversight, and
direction of all manufacturing processes, procedures, compliance
measures, and standards.
- Oversee, manage, and develop Directors of Manufacturing,
Process Excellence, Adjuvant and Microbial production, Compliance,
Projects and Training.
- Serve as an integral member of the Seattle Site Leadership Team
(LT), and collaborate with other LT members to inspire and mobilize
the site to achieve vision and goals by contributing to site
strategy decisions.
- Partner with the QA group to develop, implement and operate
quality systems aligned with company standards as well as ensure
alignment between Manufacturing and Quality in pursuit of
interdependence and fulfilling quality goals.
- Ensuring the manufacturing facility is in a continuous state of
readiness for production and cGMP audits. This will include
completing quality work on schedule and in a safe manner, and
ensuring the manufacturing area complies with all regulatory
requirements.
- Develop a Master Plan maximizing the use of current site assets
while developing plans with factoring in for future growth.Drive
continuous improvement activities, strategy development and
delivery, as well as supporting organizational development and
cultural leadership.
- Assess the effectiveness and efficiency of site wide systems,
processes and practices as well as oversee the planning and
implementation of cost-effective initiatives that increase
efficiency, effectiveness, throughput and regulatory
compliance.
- Coordinate with other global sites on operational
strategies/opportunities, capacity planning/optimization,
technology/process development, and operational/quality
initiatives. Ensure that all technology transfer, new project
start-ups, and manufacturing campaigns are executed to company and
customer requirements.
- Evaluate the results of the business and communicate with key
stakeholders on current and anticipated performance to facilitate
effective planning and decision-making. Lead the development of an
operating plan that accounts for expanded capacity, improved
productivity, asset flexibility, customer dynamics, and higher
utilization rates to ensure that this business achieves overall
financial goals for revenues, earnings, and ROI.
- Ensure good working relationships with all customers, suppliers
and business partners including overall compliance with relevant
FDA, OSHA, EPA and quality requirements.
KNOWLEDGE, SKILLS & ABILITIES:
- Staff Leadership -Translate mission, vision, values into
actionable goals and objectives. Provide adequate structure,
direction and feedback. Create environment where staff feel valued,
respected and empowered as well as show appreciation for and
rewards individual and group excellence. Demonstrate high standards
of ethics and fairness, and work through conflict and insures
productive resolution.
- Job Knowledge and Skills - Possess required knowledge and
skills to successfully perform job. Rapidly embraces and applies
new ideas and approaches where doing so adds value.
- Results Orientation - Know how to get things done in an
effective and efficient manner with available resources. Plan and
prioritizes work, sets and accomplishes goals, and completes
quality work on schedule. Maintain a sense of urgency in
accomplishing work, and strive to improve company and individual
performance. Take personal responsibility, leads by example and
conscientious.
- Decision Making -Make timely and sound decisions based on a
combination of analysis, experience and judgment. Understand and
take into consideration how decisions affects others.
- Customer Focus/Team Work - Develop and maintain adequate
customer satisfaction levels with internal and external audiences.
Demonstrate a bias toward service, quality and teamwork. Build
constructive and effective working relationships and is committed
to the success of all stakeholders. Cultivate a culture of openness
and information sharing. Demonstrate integrity and honesty in all
communication - being able to take and provide constructive
feedback.
EDUCATION/EXPERIENCE:
- BS in Biology, Biochemistry, Molecular Biology or related
technical discipline is required; MBA and/or a graduate degree in a
related technical discipline is highly desired.
- Significant leadership experience of a manufacturing
organization with multi-product operations. Ideally, this
experience will include the launch and commercialization of cGMP
biopharmaceuticals.
- Business and technically savvy executive who has successfully
managed and optimized cGMP biologics manufacturing operations
and/or relevant cGMP biotechnology businesses
- Success in collaborating with prospective and current clients
to build and maintain effective and trusting
relationships.
- Inherent in this role is the delivery of results through a
combination of operational excellence, organizational development,
and business management skills.
- Proven capability to develop a strong market presence through
customer service, high quality services, and technology
leadership.
- Demonstration of excellent communication skills to support team
building, internal and external communications, and industry
leadership opportunities.
- Extensive skill and experience leading transformative
manufacturing and productivity initiatives (e.g. lean/six sigma) to
improve performance in a cGMP environment.
- Experience in a rapidly growing, biopharmaceutical or related
biotechnology business.
- Equivalent education or experience may substitute for stated
requirements.
COMPENSATION RANGE:
$229,000 - $314,000
Fluctuations in the job market may necessitate adjustments to pay
ranges. Final pay determinations will depend on various factors,
including, but not limited to experience levels, knowledge, skills,
and abilities.
Benefits available to Team Members include subsidized insurance for
the Team Member and designated dependents (medical, vision, dental,
life and disability), eligibility to participate in the AGC
Biologics 401(k) plan (including a generous matching contribution
from the company and immediate vesting), vacation, sick time, and
parental leave.
Team Members are also eligible to receive a discretionary annual
bonus commensurate to the level of the role. The payout is based on
both the company's performance and the Team Member's
performance.
AGC Biologics offers a highly competitive compensation package and
a friendly, collaborative culture that values personal initiative
and professional achievement. AGC Biologics is an equal opportunity
employer. All qualified applicants will receive consideration for
employment without regard to age, ancestry, color, family or
medical care leave, gender identity or expression, genetic
information, marital status, medical condition, national origin,
physical or mental disability, political affiliation, protected
veteran status, race, religion, sexual orientation, or any other
characteristic protected by applicable laws, regulations and
ordinances.
LI-LH1
Keywords: Agcbio, Seattle , Vice President of Manufacturing, Executive , Seattle, Washington
Didn't find what you're looking for? Search again!
Loading more jobs...