Shoreline Biosciences, Inc.
Associate Director, Manufacturing Science and Technology
Shoreline Biosciences, Inc., San Diego, California, United States, 92189
Company Summary:
Located in San Diego, CA, Shoreline Biosciences, Inc. is focused on changing the lives of patients and families living with cancer by developing safe, highly effective, and accessible allogeneic NK and macrophage cell therapies. Shoreline was recognized by the California Life Sciences as the Pantheon 2021 award winner for the Strategic Partnership of the Year Award. Join our winning team!
Position Summary:
The Associate Director, Manufacturing Science and Technology (MSAT) leads the technology transfer of manufacturing processes from process development to the manufacturing environment both internally and externally. In addition, the AD, MSAT is responsible for the troubleshooting of ongoing manufacturing operations. The anticipated salary range for this position is $108,000 to $203,000. The final salary offered to a successful candidate is dependent on the candidate's experience, qualifications, geographic location, and other job-related factors. In addition to base salary, the hired candidate is eligible to receive an annual bonus and will receive an equity grant, at the time of hire, in the form of the option to purchase stock in the future for a specified price.
Primary Responsibilities:
Responsible for tech transfer of manufacturing processes to internal and external manufacturing groups. Collaborate with Process Development and Manufacturing to author and review SOPs, Batch Records, CAPAs, Investigations and Deviations. Design and review experimental plans, analyze and summarize data, author technical reports, define and implement recommendations for process optimization. Contribute to CMC sections of INDs, BLAs, and other regulatory documents for FDA and other international regulatory agencies. Participate in product and process FMEAs and related drug development risk management processes. Establish tracking and trending analyses of process development and cGMP production runs. Participate in the evaluation of reagents and raw materials to ensure compliance with regulatory health agency standards and process suitability. Drive continuous process improvements to enhance quality, yield, throughput, and reduce cycle time, cost, labor, waste. Provide technical expertise and leadership within project teams and in a matrix environment. Collaborate with internal and external groups to lead scale up of iPSC derived cell therapy manufacturing. Collaborate closely with other functions to enable effective and successful project development; actively engage in cross-functional collaboration with peers to overcome challenges. Organize, communicate, and present complex data sets to key stakeholders and senior management. Management Responsibilities:
Hires, trains, and develops MSAT team members. Qualifications:
Education & Experience
BS Degree in Biomedical Engineering or similar with 14+ years of experience in process development, MSAT or manufacturing. Advance degree such as a PhD or MSc in Biotechnology, Bioprocess/Biomedical Engineering, Immunology, Cell/Molecular Biology, Biochemistry, highly preferred, with 10+ years of industry experience. Experience managing junior staff, including goal setting and performance evaluations. Experience supporting or authoring MSAT sections of regulatory submissions, such as IND and BLA. Skills & Knowledge:
Working knowledge of cGMP requirements and Quality by Design (QBD) principles. Strong leadership skills and strategic problem-solving ability; ability to predict issues and identify solutions. Self-motivated, excellent time management, organizational, and proven problem-solving skills. Outstanding written and verbal communication skills. Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit. The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. Transition from standing and sitting often. Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. This position requires the ability to occasionally lift and/or move up to 10 pounds. Work Environment:
Will require working with cells and cell lines of human and/or animal origin. Will require working with hazardous materials. Work in and around common laboratory equipment. The regular requirements of an office environment (computers, computer screens, workstations, etc.) apply when not working in or around a laboratory environment. 100% on-site work at corporate headquarters in San Diego, CA. Evening and weekend work as necessary. Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Visit our website to find out more about Shoreline Biosciences:
https://www.shorelinebio.com/ . EEO Employer: Shoreline Biosciences, Inc., is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected classification.
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Located in San Diego, CA, Shoreline Biosciences, Inc. is focused on changing the lives of patients and families living with cancer by developing safe, highly effective, and accessible allogeneic NK and macrophage cell therapies. Shoreline was recognized by the California Life Sciences as the Pantheon 2021 award winner for the Strategic Partnership of the Year Award. Join our winning team!
Position Summary:
The Associate Director, Manufacturing Science and Technology (MSAT) leads the technology transfer of manufacturing processes from process development to the manufacturing environment both internally and externally. In addition, the AD, MSAT is responsible for the troubleshooting of ongoing manufacturing operations. The anticipated salary range for this position is $108,000 to $203,000. The final salary offered to a successful candidate is dependent on the candidate's experience, qualifications, geographic location, and other job-related factors. In addition to base salary, the hired candidate is eligible to receive an annual bonus and will receive an equity grant, at the time of hire, in the form of the option to purchase stock in the future for a specified price.
Primary Responsibilities:
Responsible for tech transfer of manufacturing processes to internal and external manufacturing groups. Collaborate with Process Development and Manufacturing to author and review SOPs, Batch Records, CAPAs, Investigations and Deviations. Design and review experimental plans, analyze and summarize data, author technical reports, define and implement recommendations for process optimization. Contribute to CMC sections of INDs, BLAs, and other regulatory documents for FDA and other international regulatory agencies. Participate in product and process FMEAs and related drug development risk management processes. Establish tracking and trending analyses of process development and cGMP production runs. Participate in the evaluation of reagents and raw materials to ensure compliance with regulatory health agency standards and process suitability. Drive continuous process improvements to enhance quality, yield, throughput, and reduce cycle time, cost, labor, waste. Provide technical expertise and leadership within project teams and in a matrix environment. Collaborate with internal and external groups to lead scale up of iPSC derived cell therapy manufacturing. Collaborate closely with other functions to enable effective and successful project development; actively engage in cross-functional collaboration with peers to overcome challenges. Organize, communicate, and present complex data sets to key stakeholders and senior management. Management Responsibilities:
Hires, trains, and develops MSAT team members. Qualifications:
Education & Experience
BS Degree in Biomedical Engineering or similar with 14+ years of experience in process development, MSAT or manufacturing. Advance degree such as a PhD or MSc in Biotechnology, Bioprocess/Biomedical Engineering, Immunology, Cell/Molecular Biology, Biochemistry, highly preferred, with 10+ years of industry experience. Experience managing junior staff, including goal setting and performance evaluations. Experience supporting or authoring MSAT sections of regulatory submissions, such as IND and BLA. Skills & Knowledge:
Working knowledge of cGMP requirements and Quality by Design (QBD) principles. Strong leadership skills and strategic problem-solving ability; ability to predict issues and identify solutions. Self-motivated, excellent time management, organizational, and proven problem-solving skills. Outstanding written and verbal communication skills. Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit. The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. Transition from standing and sitting often. Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. This position requires the ability to occasionally lift and/or move up to 10 pounds. Work Environment:
Will require working with cells and cell lines of human and/or animal origin. Will require working with hazardous materials. Work in and around common laboratory equipment. The regular requirements of an office environment (computers, computer screens, workstations, etc.) apply when not working in or around a laboratory environment. 100% on-site work at corporate headquarters in San Diego, CA. Evening and weekend work as necessary. Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Visit our website to find out more about Shoreline Biosciences:
https://www.shorelinebio.com/ . EEO Employer: Shoreline Biosciences, Inc., is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected classification.
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