Senior Scientist - Cell Culture
Andelyn Biosciences, Inc | Columbus | Full-time | app.trinethire.com |
Overview of Andelyn Biosciences
Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH, the company has expanded to three buildings with more than 250,000 combined square feet of space.
The Andelyn Corporate Center (ACC) is dedicated to cGMP manufacturing, the Andelyn Development Center (ADC) for preclinical non-cGMP activities, and the Andelyn Plasmid Center (APC) for research and cGMP plasmid production.
Our Values are founded in our origin story.
The name “Andelyn” is a hybrid of two gene therapy patients who participated in pivotal Phase I clinical trials at Nationwide Children’s Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006.
Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names to represent all the families who have courageously participated in the research that makes today’s gene therapies possible.
Through this journey, we have been able to accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. We are Pioneering Solutions that Turn Hope into Reality™ through our ACCTSions.
ACCOUNTABLE in our actions.
CURIOUS to discover.
COMPASSIONATE in our thinking.
TRUSTWORTHY in our communications.
SUPPORTIVE of one another.
Employees are expected to perform the following essential functions under the framework of our ACCTSions.
What you will do.
The GMP Operations Senior Scientist is responsible for guiding all aspects of Good Manufacturing Practices (GMP) and production in the Clinical Manufacturing Facility (CMF). Working in close collaboration with the Manager and Supervisor of GMP Operations, the Senior Scientist will provide hands-on support and leadership for all day-to-day GMP production operations, including project timeline management and personnel.
The Senior Scientist will aid in production efforts to deliver all products in a timely, compliant, and fiscally responsible fashion by providing leadership to staff working in the manufacturing facility as well as hands-on training to facilitate operations consistently following appropriate practices, batch records, and Standard Operating Procedures (SOPs) for manufacturing.
• Solving, correcting, preventing problems, and performing tasks as assigned by leadership, as well as assigning tasks to junior staff.
• Work on specific measurable objectives requiring operational planning skills with little direct supervision.
• Leads and supports a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of the team and goals.
• Responsible for providing leadership in daily operational activities related to the GMP manufacturing of biological products, by leading and executing production processes including assuring the availability of materials and the proper documentation surrounding GMP activities and product quality.
• Responsible for setting and maintaining a professional standard within the GMP area.
• Responsible for working with GMP Management to enact the strategic direction of the GMP area.
• Responsible for supporting GMP resources and the supply chain including ordering and maintaining materials inventory to meet production goals.
• Responsible for maintaining a high standard of accurate documentation on all GMP operations.
• Responsible for the training and supervision of junior staff to ensure the proper operation of facility equipment as well as the adherence to appropriate and accurate documentation surrounding GMP activities and product quality.
• While working with GMP management and Quality Assurance the Senior Technician guides the Operations Staff in deviation investigations, OOS results, and process troubleshooting.
• Works in close collaboration with GMP Management to ensure continuous improvement objectives are identified and met using metrics and other statistical means.
• Works in close collaboration with GMP Management to ensure new projects and technologies are sought for incorporation into the GMP area.
• Respond to, and take action from, alarm notifications from the applicable monitoring system(s) for laboratory temperature-controlled storage units that occur at any point during the assigned period of responsibility.
• Exercise discretion, judgment, and personal responsibility.
• Demonstrate a high level of integrity.
• Maintain a positive attitude.
• Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the CMF
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
• Attention to detail in all job functions.
• Performs in accordance with established policies, procedures, and techniques and requires training common experience, or working knowledge related to the tasks performed.
• Solving, correcting, and preventing problems and performing tasks as assigned by leadership, as well as assigning tasks to junior staff.
• Work on specific measurable objectives requiring operational planning skills with little direct supervision.
• Leads and supports a diverse and collaborative team environment.
• Utilizes clear and concise communication to deliver high productivity and contribution to the success of the team and goals.
• Documentation of all activities performed according to SOPs.
• Make decisions based on established procedures.
• Has fiscal responsibility.
• Moderate involvement in audits
• Infrequent travel is required.
• Moderate involvement in audits.
• Moderate involvement in customer relations.
• Moderate responsibility for inspection outcomes
• Influences hiring, development, and related personnel processes.
• Mentoring and professional development of staff.
• Other duties as assigned.
What you bring to the team.
• Must possess relevant four-year degree OR relevant master’s OR relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred.
• Five years relevant (w/4 YR deg) OR two years (w/Masters)
• Experience in biologics or gene therapy preferred.
• Experience in highly regulated field preferred.
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
• Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting.
• Ability to work independently as well as collaboratively in a diverse and inclusive work environment.
• Must possess a client-focused mindset in daily tasks.
• Must possess prior experience handling confidential information and the ability to maintain confidentiality.
• Attention to detail in all job functions.
• Infrequent travel is required.
• Demonstrate a high level of integrity.
• Maintain a positive attitude.
• Attention to detail in all job functions.
What you can expect when working at Andelyn.
• The pride of contributing to the development and manufacturing of life-saving therapies
• The invaluable experience of being a part of building the foundation of a new organization.
• The opportunity to work alongside experts who have over 10 years in the gene therapy field.
• Competitive compensation
• Eligible on day one for medical, dental, and vision insurance plans with basic vision at 100% company-paid
• 160 hours of Paid Time Off annually
• 11 Company Paid Holidays plus 2 floating holidays annually.
• Company Paid Life Insurance
• 401(k) Match
• Company Paid short and long-term disability.
• 4 weeks of Paid Parental Leave for birth and adoption
• Adoption Assistance
• Tuition Reimbursement and Student Loan Repayment Assistance
• Company Paid LinkedIn Learning access.
• Employee Assistance Programs
• Flexible work options (role specific)
Andelyn Biosciences embraces diversity and is an equal opportunity employer and does not discriminate based on race, religion, national origin, gender, gender identity, genetic information, sexual orientation, protected veteran status, disability, age, or another legally protected status.
As an organization, we are committed to creating an environment where everyone ACCTS.
Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH, the company has expanded to three buildings with more than 250,000 combined square feet of space.
The Andelyn Corporate Center (ACC) is dedicated to cGMP manufacturing, the Andelyn Development Center (ADC) for preclinical non-cGMP activities, and the Andelyn Plasmid Center (APC) for research and cGMP plasmid production.
Our Values are founded in our origin story.
The name “Andelyn” is a hybrid of two gene therapy patients who participated in pivotal Phase I clinical trials at Nationwide Children’s Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006.
Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names to represent all the families who have courageously participated in the research that makes today’s gene therapies possible.
Through this journey, we have been able to accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. We are Pioneering Solutions that Turn Hope into Reality™ through our ACCTSions.
ACCOUNTABLE in our actions.
CURIOUS to discover.
COMPASSIONATE in our thinking.
TRUSTWORTHY in our communications.
SUPPORTIVE of one another.
Employees are expected to perform the following essential functions under the framework of our ACCTSions.
What you will do.
The GMP Operations Senior Scientist is responsible for guiding all aspects of Good Manufacturing Practices (GMP) and production in the Clinical Manufacturing Facility (CMF). Working in close collaboration with the Manager and Supervisor of GMP Operations, the Senior Scientist will provide hands-on support and leadership for all day-to-day GMP production operations, including project timeline management and personnel.
The Senior Scientist will aid in production efforts to deliver all products in a timely, compliant, and fiscally responsible fashion by providing leadership to staff working in the manufacturing facility as well as hands-on training to facilitate operations consistently following appropriate practices, batch records, and Standard Operating Procedures (SOPs) for manufacturing.
• Solving, correcting, preventing problems, and performing tasks as assigned by leadership, as well as assigning tasks to junior staff.
• Work on specific measurable objectives requiring operational planning skills with little direct supervision.
• Leads and supports a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of the team and goals.
• Responsible for providing leadership in daily operational activities related to the GMP manufacturing of biological products, by leading and executing production processes including assuring the availability of materials and the proper documentation surrounding GMP activities and product quality.
• Responsible for setting and maintaining a professional standard within the GMP area.
• Responsible for working with GMP Management to enact the strategic direction of the GMP area.
• Responsible for supporting GMP resources and the supply chain including ordering and maintaining materials inventory to meet production goals.
• Responsible for maintaining a high standard of accurate documentation on all GMP operations.
• Responsible for the training and supervision of junior staff to ensure the proper operation of facility equipment as well as the adherence to appropriate and accurate documentation surrounding GMP activities and product quality.
• While working with GMP management and Quality Assurance the Senior Technician guides the Operations Staff in deviation investigations, OOS results, and process troubleshooting.
• Works in close collaboration with GMP Management to ensure continuous improvement objectives are identified and met using metrics and other statistical means.
• Works in close collaboration with GMP Management to ensure new projects and technologies are sought for incorporation into the GMP area.
• Respond to, and take action from, alarm notifications from the applicable monitoring system(s) for laboratory temperature-controlled storage units that occur at any point during the assigned period of responsibility.
• Exercise discretion, judgment, and personal responsibility.
• Demonstrate a high level of integrity.
• Maintain a positive attitude.
• Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the CMF
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
• Attention to detail in all job functions.
• Performs in accordance with established policies, procedures, and techniques and requires training common experience, or working knowledge related to the tasks performed.
• Solving, correcting, and preventing problems and performing tasks as assigned by leadership, as well as assigning tasks to junior staff.
• Work on specific measurable objectives requiring operational planning skills with little direct supervision.
• Leads and supports a diverse and collaborative team environment.
• Utilizes clear and concise communication to deliver high productivity and contribution to the success of the team and goals.
• Documentation of all activities performed according to SOPs.
• Make decisions based on established procedures.
• Has fiscal responsibility.
• Moderate involvement in audits
• Infrequent travel is required.
• Moderate involvement in audits.
• Moderate involvement in customer relations.
• Moderate responsibility for inspection outcomes
• Influences hiring, development, and related personnel processes.
• Mentoring and professional development of staff.
• Other duties as assigned.
What you bring to the team.
• Must possess relevant four-year degree OR relevant master’s OR relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred.
• Five years relevant (w/4 YR deg) OR two years (w/Masters)
• Experience in biologics or gene therapy preferred.
• Experience in highly regulated field preferred.
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
• Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting.
• Ability to work independently as well as collaboratively in a diverse and inclusive work environment.
• Must possess a client-focused mindset in daily tasks.
• Must possess prior experience handling confidential information and the ability to maintain confidentiality.
• Attention to detail in all job functions.
• Infrequent travel is required.
• Demonstrate a high level of integrity.
• Maintain a positive attitude.
• Attention to detail in all job functions.
What you can expect when working at Andelyn.
• The pride of contributing to the development and manufacturing of life-saving therapies
• The invaluable experience of being a part of building the foundation of a new organization.
• The opportunity to work alongside experts who have over 10 years in the gene therapy field.
• Competitive compensation
• Eligible on day one for medical, dental, and vision insurance plans with basic vision at 100% company-paid
• 160 hours of Paid Time Off annually
• 11 Company Paid Holidays plus 2 floating holidays annually.
• Company Paid Life Insurance
• 401(k) Match
• Company Paid short and long-term disability.
• 4 weeks of Paid Parental Leave for birth and adoption
• Adoption Assistance
• Tuition Reimbursement and Student Loan Repayment Assistance
• Company Paid LinkedIn Learning access.
• Employee Assistance Programs
• Flexible work options (role specific)
Andelyn Biosciences embraces diversity and is an equal opportunity employer and does not discriminate based on race, religion, national origin, gender, gender identity, genetic information, sexual orientation, protected veteran status, disability, age, or another legally protected status.
As an organization, we are committed to creating an environment where everyone ACCTS.
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