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Sr Mgr, Manufacturing Operations
3 months ago
Senior Manager, Manufacturing
Operations
– J.POD Cell Culture
The focus of this
role
is to guide the successful execution of upstream clinical and commercial manufacturing operations while ensuring cGMP compliance.
This position
is responsible
for supervising and overseeing multiple shifts to cover 24/7 operation
s
and requires significant on-the-floor presence, as well as technical subject matter expertise in cell culture operations.
Additional
job responsibilities include generation and maintenance of cGMP manufacturing and technical documentation, troubleshooting and/or providing technical
expertise
to perform troubleshooting efforts or lead investigations, ensuring staff training and compliance, execution of plant start-up commissioning and validation activities, and implement
ation
and
maintenance of
required cGMP compliant systems
.
Th
is individual may
also
participate
in finite scheduling, aspects of technology and/or process transfer,
identify
process gaps and technology issues,
determine
solutions and remediation plans, provide support for regulatory and site inspections, and provide input to department capital and expense budgets.
Responsibili
ty level
s:
Provide
expertise
and make
decisions that
impact
project teams brings in
new technologies
& literature
"
Use technical
expertise
to design/ implement new equipment, new disposable assemblies, or new molecule projects without guidance of prior protocols
.
Provide
technical guidance to others within the company - develop new
protocols
H
igh complexity, high (multi
molecule)impact
, challenging systems, coordinate interconnected systems/equipment, ID trends or
non obvious
issues/error traps/prevention
Coordinate with leadership to
i
nitiate
and lead new teams to
address technical
challenges "
Communicate and/or present technical information to a diverse set of audiences, including senior management, regulatory agencies, and
clients -
bridge to Sr manager - more targeted communication
Be
a technical resource in multiple operational areas within functional group
.
Possess
a deeper understanding of regulatory requirements
.
Contribute/ lead implementation of
new technology
or technical improvements
.
Represent Just
externally
Lead a
Process or cross-company team. Lead investigations of operational/ quality issues. Lead
and develop
direct reports
in the upstream functional areas
with
direct reports. SME for specialized areas (
ex.training
)
Establish culture and hire to fit."
Develop an emotionally intelligent organizational culture that values diversity, encourages open communication, and supports employee well-being.
Supervise managerial tasks and team
objectives
.
A
pply emotional intelligence in negotiations, understanding the emotional needs of stakeholders, and finding mutually beneficial solutions.
Consider the emotional impact of business decisions on various stakeholders, including employees, customers, and the community.
Educational Requirements:
Master’s degree and 6 years of Manufacturing or Operations experience; or
Bachelor’s degree and 8 years of Manufacturing or Operations experience
Qualification
requirement
s:
Proven knowledge of cGMP requirements to ensure
compliance
Significant experience
in operations
required
for the manufacture of
biotherapeutics
Proven record of accomplishment managing,
supervising
and developing staff
Candidate must
possess
strong focus on quality and attention to
detail
Excellent communication with senior leadership
Possess effective task/time management organizational
skills
Capacity
to develop solutions to technical issues of challenging
scope
Ability to organize, analyze/interpret, and effectively communicate data and
results
Motivated, self-starter with strong mechanical aptitude
Good interpersonal, team, and communication skills are
a
must
Significant contributor to multi-disciplinary teams at the functional level; mentors and
provides
technical advice to individuals within the
team
Excellent oral and written communication skills
Additional Preferred Qualifications:
In-depth knowledge of biotech equipment, operations, and engineering principles
Recognized technical mastery of disposable manufacturing technologies at commercial
scale
Participation in client and regulatory agency audits
Change control, NC/CAPA, and
deviations
Fundamental understanding and basic operation of process automation (
DeltaV
)
Experienced in technology and/or process transfer for
late stage
clinical manufacturing or commercial qualification campaigns; commercial campaign support
Application of knowledge and
expertise
to solve complex technical problems; may apply novel approach that provides significant technology
advancement
Active participation/lead technical projects with collaborators and vendors
Experience with finite scheduling tools and allocation of resources and
equipment
This job description
is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job.
It is not to be construed as an exhaustive statement of duties,
responsibilities,
or requirements.
Because job requirements evolve with the changing needs of
Just
-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
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