Catalent
Sr. Manager Upstream Process Development
Catalent, Baltimore, Maryland, United States, 21276
JOB DESCRIPTION :
Lead client projects from development and optimization toward cGMP manufacturing for clinical trials, registration, or improvements of existing processes and products.
Interact and collaborate with clients regarding the Upstream activities of the program, including design and execution of experiments, analysis, and presentation of experimental results.
Act as subject matter expert in Upstream Process Development of biologics, including, but not limited to vaccines, viral vectors, and recombinant proteins.
Provide expertise on both small and large scale process development activities including cell line development, optimization studies in shake flasks and 2-5L scale bioreactors, as well as execution of 10-200L scale bioreactors.
Extensive experience with single-use bioreactors and systems preferred.
Lead the training and evaluation of product harvest and recovery strategies based on product type and client requirements.
Develop and execute large scale (50 – 200 liter) productions and harvest protocols utilizing technical knowledge to scale-up to manufacturing scales.
Assist technology transfer group in drafting PFDs and reviewing them. Provide technical support in engineering and GMP runs.
Lead and participate in decision-making processes within the project team by actively engaging in scientific and technical discussions.
Expand the technical capabilities of the Process Development group by offering expertise in areas such as technology development, platform or systems development, or using literature precedent.
Manage and lead junior staff to ensure optimum utilization of resources on the following:
Planning daily, weekly, monthly schedules.
Goal setting and performance reviews.
Teaching others in their area of expertise and assisting with work performed by other members of the Upstream Process Development group.
Communicate with different departments to ensure successful transfer of processes from PD to cGMP manufacturing.
Plan, develop, organize, and implement policies, procedures, and standards for lab operations to ensure efficiency, optimal performance, and quality control of the laboratory while maintaining company standards and compliance with federal, state, and local regulations.
Manage daily lab operations; support all lab scientists by managing and providing resources required to perform all aspects of their work.
Coordinate the ordering, inventory, storage, and maintenance of supplies, lab disposables, and instruments essential to laboratory operations.
Maintain a safe and compliant laboratory work environment: coordinate with the EHS manager to implement EHS initiatives; work with team leaders to facilitate compliance with EHS policies and procedures; and assist Facilities Engineering to ensure laboratory compliance with regulatory codes.
In coordination with the EHS Manager, oversee the environmental health and safety program in the laboratory, assist safety professionals and licensing agencies, and interface with building facility representatives for facilities-related matters.
EDUCATION AND EXPERIENCE REQUIREMENT : Bachelor’s degree in Biology, Biochemistry/Chemistry, and 7 years of experience in the job offered or 7 years of experience in a related occupation.
RELATED OCCUPATION:
Associate Scientist or any other job title performing the following job duties:
Leading client projects from development and optimization toward cGMP manufacturing for clinical trials, registration, or improvements of existing processes and products.
Aiding in design and execution of experiments to develop and improve scalable protein production processes utilizing different expression systems with a focus on mammalian and insect cell cultures.
Providing hands-on support to the team executing experiments to generate material for production of recombinant proteins and viral vectors from flasks to bioreactors.
Leading a team of scientists and engineers involved in process development, coaching and mentoring them to fulfill both group and individual performance goals.
Interacting with appropriate analytical and downstream functional areas to determine appropriate methods for culture harvest and protein recovery.
Collecting, analyzing, and interpreting experimental data for reports and presentations.
Developing and executing large scale (50 – 200 liter) productions and harvest protocols utilizing technical knowledge to scale-up to manufacturing scales.
Understanding and application of aseptic techniques.
Performing cell culture handling, cell growth characterization, and optimization at different scales.
Producing material at different scales using various platforms from flasks to stirred-tanks and packed bed bioreactors.
Instrument care, maintenance, troubleshooting, and data interpretation.
Writing standard operating procedures, protocols, process flow diagrams, and batch records.
Participating in decision-making processes within the project team by actively engaging in scientific and technical discussions.
Interacting with clients to report data, discuss results, and present the design of experiments and study plans.
SALARY RANGE:
$122,034.00 to $146,049.00/year
JOB TIME:
Full Time
Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma, and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
Personal initiative. Dynamic pace. Meaningful work.
Visit
Catalent Careers
to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
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, confirming your request for an accommodation, and including the job number, title, and location to
DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local 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.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number, or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice
HERE .
#J-18808-Ljbffr
Lead client projects from development and optimization toward cGMP manufacturing for clinical trials, registration, or improvements of existing processes and products.
Interact and collaborate with clients regarding the Upstream activities of the program, including design and execution of experiments, analysis, and presentation of experimental results.
Act as subject matter expert in Upstream Process Development of biologics, including, but not limited to vaccines, viral vectors, and recombinant proteins.
Provide expertise on both small and large scale process development activities including cell line development, optimization studies in shake flasks and 2-5L scale bioreactors, as well as execution of 10-200L scale bioreactors.
Extensive experience with single-use bioreactors and systems preferred.
Lead the training and evaluation of product harvest and recovery strategies based on product type and client requirements.
Develop and execute large scale (50 – 200 liter) productions and harvest protocols utilizing technical knowledge to scale-up to manufacturing scales.
Assist technology transfer group in drafting PFDs and reviewing them. Provide technical support in engineering and GMP runs.
Lead and participate in decision-making processes within the project team by actively engaging in scientific and technical discussions.
Expand the technical capabilities of the Process Development group by offering expertise in areas such as technology development, platform or systems development, or using literature precedent.
Manage and lead junior staff to ensure optimum utilization of resources on the following:
Planning daily, weekly, monthly schedules.
Goal setting and performance reviews.
Teaching others in their area of expertise and assisting with work performed by other members of the Upstream Process Development group.
Communicate with different departments to ensure successful transfer of processes from PD to cGMP manufacturing.
Plan, develop, organize, and implement policies, procedures, and standards for lab operations to ensure efficiency, optimal performance, and quality control of the laboratory while maintaining company standards and compliance with federal, state, and local regulations.
Manage daily lab operations; support all lab scientists by managing and providing resources required to perform all aspects of their work.
Coordinate the ordering, inventory, storage, and maintenance of supplies, lab disposables, and instruments essential to laboratory operations.
Maintain a safe and compliant laboratory work environment: coordinate with the EHS manager to implement EHS initiatives; work with team leaders to facilitate compliance with EHS policies and procedures; and assist Facilities Engineering to ensure laboratory compliance with regulatory codes.
In coordination with the EHS Manager, oversee the environmental health and safety program in the laboratory, assist safety professionals and licensing agencies, and interface with building facility representatives for facilities-related matters.
EDUCATION AND EXPERIENCE REQUIREMENT : Bachelor’s degree in Biology, Biochemistry/Chemistry, and 7 years of experience in the job offered or 7 years of experience in a related occupation.
RELATED OCCUPATION:
Associate Scientist or any other job title performing the following job duties:
Leading client projects from development and optimization toward cGMP manufacturing for clinical trials, registration, or improvements of existing processes and products.
Aiding in design and execution of experiments to develop and improve scalable protein production processes utilizing different expression systems with a focus on mammalian and insect cell cultures.
Providing hands-on support to the team executing experiments to generate material for production of recombinant proteins and viral vectors from flasks to bioreactors.
Leading a team of scientists and engineers involved in process development, coaching and mentoring them to fulfill both group and individual performance goals.
Interacting with appropriate analytical and downstream functional areas to determine appropriate methods for culture harvest and protein recovery.
Collecting, analyzing, and interpreting experimental data for reports and presentations.
Developing and executing large scale (50 – 200 liter) productions and harvest protocols utilizing technical knowledge to scale-up to manufacturing scales.
Understanding and application of aseptic techniques.
Performing cell culture handling, cell growth characterization, and optimization at different scales.
Producing material at different scales using various platforms from flasks to stirred-tanks and packed bed bioreactors.
Instrument care, maintenance, troubleshooting, and data interpretation.
Writing standard operating procedures, protocols, process flow diagrams, and batch records.
Participating in decision-making processes within the project team by actively engaging in scientific and technical discussions.
Interacting with clients to report data, discuss results, and present the design of experiments and study plans.
SALARY RANGE:
$122,034.00 to $146,049.00/year
JOB TIME:
Full Time
Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma, and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
Personal initiative. Dynamic pace. Meaningful work.
Visit
Catalent Careers
to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
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, confirming your request for an accommodation, and including the job number, title, and location to
DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local 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.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number, or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice
HERE .
#J-18808-Ljbffr