It is an exciting time to join us!t

Andelyn Biosciences is an industry-leading cGMP production facility dedicated to advancing the field of gene therapy.  Our mission is to use our knowledge, resources, technology, and experience in the field of translational and regulatory science, to develop new, safe, and effective long-term treatments for diseases.  There is no disease too rare and no challenge too difficult as we strive to make a difference with every product and to leave hope in the minds of every patient and their families.  Andelyn is primarily a full-service manufacturer of Adeno Associated Viruses (AAV).  We work with over 100 clients each year to manufacture AAV in development, toxicology, clinical and commercial.

Schedule: Full-time (Benefits Eligible) 

Location:   Andelyn Corporate Center 

                   1180 Arthur E. Adams Dr.

                      Columbus, OH 43221

PRINCIPAL DUTIES AND RESPONSIBILITIES

·        Support Vector teams as OPS representatives which includes participation in the development or execution of strategy, scheduling, and supply for a clinical cell therapy program.

·        Support execution, scheduling, and coordination of GMP activities within the cleanroom while collaborating with supporting functions including Quality, Quality Control, Facilities, and MSAT

·        Ensure all daily manufacturing tasks are completed following standard operating procedures and batch document instructions, completing forms, reports, logs, and records of equipment, and batches as required.

·        Lead or support Technology Transfer as the receiving unit including participation in tech transfer team(s), generation of related documents including protocols, training plans, batch records, SOPs, reports, and/ or regulatory documents such as IND.

·        Lead development of training programs and advancement/ improvement of training metrics

·        Confirm all training assignments for the team are complete and up to date, to maintain necessary technical skills and knowledge.

·        Actively participate in problem identification, problem-solving, and change initiatives in cooperation with other teams and functions.

·        Work with cross-functional teams to review internal processes and support continuous improvement activities.

·        Guide and collaborate with internal/external technical groups to ensure the on-time success of New Product Introduction and Technology Transfer activities, including handling and solving complex problems that may result in significant delays or inhibit program success.

·        Working together with the supply planner, develop and optimize supply models and define manufacturing schedules based on overall program knowledge and capabilities, including but not limited to technology-specific limitations, expiration dating, manufacturing timelines, development activities, and regulatory requirements.

·        Exercise discretion, judgment, and personal responsibility

·        Demonstrate a high level of integrity.

·        Maintain a positive attitude.

·        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.

·        Develop and define measurable objectives for the staff within their functional units to fit the objectives of the overall organization. Also is involved in organizational objectives on an executive level.

·        Cultivate a diverse and collaborative team environment. Utilizes clear and concise communication to ensure high productivity and contribution to the success of organizational goals.

·        Ultimate oversight of the development and enforcement of procedures and controls

·        Complete budgetary control over the functions under their control also influences the organizational budget establishment.

·        Some travel is required.

·        Responsible for hiring, development, and related personnel processes.

·        Mentoring and professional development of staff

·        Make use of essential people skills, including the ability to develop subordinates.

·        Ability to manage and influence people in the direct and lateral support structure.

·        Ultimate decision-making latitude within their functional units and influences decisions on an organizational level.

·        Drives timelines and development through broad influence.

·        Develop and direct short and near-term goals.

·        Responsible for developing 3–5-year business plan.

·        Interprets Regulations for application within their functional unit.

·        Has business acumen and considers business impacts in planning and problem-solving.

·        Other duties as assigned.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED

·        Must possess a relevant four-year degree OR relevant Masters OR relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred.

·        Broad knowledge of the field with proven leadership skills

·        Prior management experience is required.

·        Second-level manager.  Manages the activities of first-level managers and/or supervisors.

·        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.

·     MINIMUM PHYSICAL REQUIREMENTS

·       

·        Frequently Sitting

·        Occasional Walking/Standing/Stooping

·        Occasional Independently lifting up to 50 pounds.

·        Occasional Talking on the phone or in-person.

·        Constant Typing on a computer keyboard

The above list of duties and minimum physical requirements is intended to describe the general nature and level of work performed by individuals assigned to this classification.  It is not to be construed as an exhaustive list of duties performed by the individual nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.    

 

Andelyn Biosciences is committed to a diverse and inclusive workplace. Andelyn is an equal opportunity employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or another legally protected status.

 

Andelyn may require proof of COVID-19 vaccination prior to your first date of employment depending on whether your role would require performing under federal contracts on behalf of Andelyn.  If required and in accordance with applicable federal guidelines, either proof of completion of an approved vaccine series will be required upon hire, or a religious and medical exemption may be considered depending upon the specific job duties.