Fill Supervisor, cGMP Manufacturing-R901625
Description
I. Overview:
The Supervisor will oversee daily operations and assist in preparation and implementation of company policies, quality systems, and training programs. The objective of the position is to ensure that projects are completed in a timely manner so that milestones are met and clients are satisfied. The role will also ensure that staff continues to be developed to keep pace with department goals and growth.
II. Specific Duties, Activities and Responsibilities:
This position generally supervises one to ten direct reports. The Supervisor spends the majority of the time assigning, reviewing, checking work, assisting in the manufacturing suites and eliminating ordinary difficulties. This person also recommends candidates for hiring, termination, prepares and conducts performance reviews and salary reviews, and applies company policies.
Qualifications
III. Position Requirements:
Education
• Ph.D. in Biotechnology, or related field with at least 2 years of experience
• MS in Biotechnology, or related field with at least 3 years of experience
• B.S/B.A. in Biotechnology, or related field with at least 6-9 years of experience
• Associates Degree/Certificate/Diploma in laboratory science with minimum of 9 years experience
• Non-degreed with a minimum of 12 years experience in a regulated laboratory
• Completed leadership training in Coaching: Bringing Out the Best in Others, Giving Recognition, Handling Emotions Under Pressure, Conducting a Collaborative Performance Review or equivalent training/experience
Experience:
• 6 - 9 years bioreactor experience preferably in a manufacturing setting for cGMP manufacturing
• Experience operating, maintaining, and troubleshooting stirred vessel bioreactors and/or proven purification expertise with varied proteins
• Aseptic technique experience
• Mammalian cell culture experience is required
• cGMP documentation and experience
• Experience writing standard operating procedures
• Experience mentoring/supervising junior staff regarding laboratory procedures
Knowledge/Skills Requirements:
Demonstrates a solid understanding of multiple applicable techniques such as:
• Ability to operate production equipment such as bioreactors, incubators, chromatography columns, filtration apparatus
• Responsible for performing purification process steps including aseptic processes, buffer preparation, chromatography and filtration steps
• Ability to execute, document, and schedule cGMP manufacturing activities
• Ability to operate within a clean room environment
• Ability to enforce quality; monitor quality of analyst lab work including review of batch records. Monitor whether repeat work or other quality issues occur and frequency of occurrence
• Proven leadership abilities; ability to oversee junior staff involvement with deviations and ability to mentor analysts regarding regulatory requirements
• Ability to transfer knowledge to others via training or mentoring of junior staff; demonstrated ability to guide others through communication and learning
• Good written and oral communication skills; exhibited by clear, concise, appropriate, timely, relay of information, well structured and organized thought process
• Ability to actively participate in conference call discussion regarding own or group work; ability to justify a point of view in a constructive and positive way with peers, supervisor, and/or clients
• Ability to relate proposal to work performed. Understanding of how task time affects project performance
• Provides continuous feedback to team members and upper management as well as performance reviews
• Proficient in the operations of a computer with MS-Excel, MS-Word as well as programs for multiple pieces of laboratory or manufacturing equipment
• Ability to write SOPs and reports independently
• Ability to complete investigation, deviation, and change control forms independently
• Ability to integrate timelines, devise batch records and meet milestones for successful project completion
• Ability to troubleshoot and problem solve in order to initiate and execute/monitor corrective action
• Ability to set deadlines and prioritize work for self, group members, and support groups/individuals involved
• Ability to perform accountabilities and responsibilities independently and provide supervisor with updates as necessary
About Catalent
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. For more information, visit
More products. Better treatments. Reliably supplied.™
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title . This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives:
Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank-you
biojbs
Job
Manufacturing
Primary Location
United States-WI-Madison
Organization
Advanced Delivery Technologies (ADT)
Schedule
Full-time