Sr Bioprocess Associate I, Antibody Drug Conjugate (ADC)

We are LOTTE BIOLOGICS! Delivering Therapies That Enable a Healthier World. 

A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide. 

Position Summary

The primary role of the Senior Bioprocess Associate I is following detailed procedures and batch records ensuring compliance with cGMP and safety requirements. The Senior Bioprocess Associate I works on assignments that are moderately complex in nature, where judgment is required in resolving problems and making routine recommendations. Work is performed in a team environment within an Antibody Drug Conjugate (ADC) facility with classified areas requiring appropriate personal protective equipment (PPE), including but not limited to Powered Air Purifying Respirators (PAPR). Additional gowning through the processing areas and maintaining clean hygiene is a requirement to control established environmental specifications. The Senior Bioprocess Associate I is a senior member of a team and will be leveraged to ensure compliance with cGMP requirements, safety, and production schedule of junior staff.

Duties & Responsibilities

• Operates control systems and processes supporting ADC process manufacturing.
• Operates all production equipment within the assigned functional area (i.e. single use mixers, single use reactors, TFF, buffer equipment, single use chromatography skids, filtration operations, isolator operations, aseptic technique, filling of final drug substance, etc.)
• Maintains files, records data, logs activities, and monitors processes.
• Prepares process buffers, media and reagents.
• Maintains area in a clean and orderly fashion to support the manufacturing schedule.
• Recognizes and reports safety, maintenance and quality events to area management.
• Communicates status of operations to area management in a timely manner.
• Achieves and maintains proficiency through training.
• Assists with reviewing batch and exception reports for each manufacturing lot in conjunction with Quality representative.
• Engages in and supports culture of continual improvement through ownership of improvement for work processes, equipment and safe work environment. 
• Consistently performs and possess the ability to train others on complex/critical operations.
• May provide support for engineering projects and departmental continuous improvement initiatives
• May work on development /improvement of manufacturing documentation (i.e. SOPs, WIs, MBRs)

Education & Experience

• The successful candidate will have a high school diploma or equivalent. Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry, or related discipline or its equivalent is desired.
• Experience in aseptic technique and purification is desired.
• A minimum of 3 years process operations experience in a biotechnology manufacturing facility subject to current Good Manufacturing Practices (cGMP) regulations.

Knowledge, Skills, Abilities

• Prior job-related experience required along with demonstrated mechanical aptitude and high level of attention to detail.
• Prior process operations experience in a biotechnology manufacturing facility or related industry subject to current Good Manufacturing Practices (cGMP) regulations.
• Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications.
• Practical knowledge of regulations such as cGMP and Standard Operating Procedures (SOP).
• Familiarity with general chemistry, mathematics, microbiology and cGMP operations is desirable.
• Work/study experience where attention to detail, adherence to written instruction, and personal accountability were critical to success.
• Demonstrated abilities for problem solving, successful participation on work teams where combined contribution, collaboration, and results were expected.
• Demonstrates good interpersonal skills, is attentive and approachable with the ability to embrace a team-based culture.
• Demonstrated ability to communicate expectations and results to the operating staff and management as needed to maintain production timelines and organizational goals.
• Demonstrated ability to inspire other to perform at a higher level. 
• Demonstrated knowledge on process/equipment/SOPs within assigned functional area

Physical Demands

This position is located in a large-scale manufacturing facility with classified areas requiring appropriate personal protective equipment (PPE), including but not limited to Powered Air Purifying Respirators (PAPR).

This role will require handling hazardous materials such as caustic, acids and high potent compounds.

Frequent bending, twisting, squatting, kneeling, climbing and reaching is required.

Role also requires infrequent unassisted lifting (not to exceed 50 lbs).

Repetitive use of arms/hand/wrists, grasping is also required.

This position is a team-based position working a standard 40-hour work week with the potential to work the occasional weekend, holiday and/or overtime.

Work Environment

The work environment involves activities in a large-scale manufacturing facility, lab space and office space. The environment includes limited exposure to noise (> 85 dBA), hazardous chemicals, high potent compounds and equipment temperature
extremes.

Target Bonus
5%

Work Location

East Syracuse, NY 

We are an Equal Employment Opportunity (“EEO”) Employer. 

We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities!  If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!