Supervisor Manufacturing

4 weeks ago

Philadelphia Pennsylvania, United States WuXi AppTec Inc Full time
Overview:
WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.

 

Responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs). 

 

Responsibilities:
Understands, oversees, trains, coaches, mentors and manages performance of
others on basic aseptic operational techniques as well as, performing solution,
material preparation, analyzing results and facility start-up engineering and
mechanical knowledge.

Understands, teaches and coaches others on all operations, functions, capability
of equipment and ancillary support to equipment and is able to perform complex
troubleshooting

Drives sourcing and purchasing of standard, new and complex equipment

Reviews and approves solution and material preparation results and resolves
issues

Reviews protocols and other technical transfer documents

Identifies and drives application of GMP concepts and is able to recommend and
identify improvements as the process develops during phases of technical transfer

Executes in-house and offsite validation activities

Forecast and performs material procurement activities

Uses all support systems (e.g. LIMS) with demonstrated proficiency and able to
act as an subject matter expert (SME) and/or Super user on a system

Acts a lead, member or Champion that helps to design the new system or of a
systems improvement team

Understands the concept of and has performed or experience with manufacturing
processes and methods

Trains, coaches mentors and manages performance of others on basic operations
such as media preparation, thaw, passage and harvesting and specific unit
operations and overall systems across assigned programs, in the manufacturing
process

Interprets data and draws conclusions

Identifies process and method gaps and opportunities and implements
improvements across assigned programs and site specific

Collects, records, reviews, performs analysis, interprets, identifies trends of
scientific and process data per good document practices

Communicates with internal and external stakeholders scientific and process data
and recommends path for forward processing

Follows compliance and regulatory requirements and current Good Manufacturing
Practices (cGMPs) and understands ‘why’ behind the regulations

Identifies, communicates, addresses and improves complex cGMP compliance
and regulatory gaps and issues across assigned programs and site specific

Responsible for ensuring employees are trained on Batch record, SOPs,
equipment, all unit operations and non-manufacturing SOPs and systems

Authors, reviews and approves technical documents such as non-conforming
events and deviations

Identifies, suggests, participates, leads, implements and champions continuous
improvement ideas

Accountable for schedule preparation, forecasting, adjustments and performance
of work assignments for team to ensure adequate staffing across assigned and
site specific programs

Regularly interacts with and supports cross-functional teams.

Accomplishes staff results by communicating updated organizational
information, job expectations & supporting their work

Plans, monitors, and appraises direct reports including performance
competencies, goals & job results

Coaches, counsels, and conducts disciplinary actions

Develops, coordinates, and follows organizational systems, policies, procedures,
and follows labor and capacity standards

Qualifications:
HS Diploma or equivalent required and

5+ years relevant technical experience and min 2 years in a
Lead/Leadership/Supervisory Role

BS/BA in Science related field preferred; or combination of relevant Experience &
Education

Knowledge / Skills / Abilities:

Demonstrated Lean / Six Sigma knowledge, desired

Ability to accurately and reproducibly perform arithmetic calculations including
fractions, decimals and percentages and basic algebraic and geometric
calculations.

Thorough understanding of Good Laboratory Practices and Good Manufacturing
Practices

Has basic financial knowledge and acumen

Possesses basic and fundamental engineering and mechanical knowledge and isable to apply in the manufacturing area demonstrating unit operational and endto-end understanding

Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy.

Proficient in Oral & Written communication skills

Need to be able to read, write and understand English

Proficient in Microsoft (Excel, Word, Outlook)

 

Our Values:

Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

 

Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

 

WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

 

 

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