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Sr Mgr, Manufacturing Operations

3 months ago

Seattle, United States Evote Full time

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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