Senior Manager, Upstream Process Development - LOTTE BIOLOGICS USA, LLC

Position Summary

The Senior Manager, Upstream Process Development leads the Mammalian Bioprocess Labs and oversees all data and documentation related to mammalian cell expansion of biopharmaceutical products. The Senior Manager drives departmental and company goals, milestones, and innovation to completion.

Duties & Responsibilities

• Drives the completion of financial business drivers (milestones, revenue generation, innovation).
• Contributes to the design of the company strategy and vision.
• Leads by example and with empathy
• Establishes good working relationships with peers and other colleagues as a team player and collaborator.
• Stays current with all training requirements.
• Follows procedures to ensure a safe working environment including but not limited to reporting safety incidents.
• Communicates with peers and other colleagues concisely and efficiently.
• Displays initiative for continuous improvement, learning new techniques, and maintaining the lab.
• Able to problem solve and critically think through processes
• Client oriented with excellent time management skills able to multitask, meet deadlines, and prioritize activities
• Executes assignments independently.
• Leads and builds a department comprised of scientist and associate teams.
• Facilitates and leads training of new employees
• Displays a positive attitude and good change readiness.
• Ability to provide technical support through troubleshooting, problem solving and collaboration.
• Able to interpret data and design subsequent experiments.

Education & Experience

• One of the following must be met:
  • Bachelor's degree in life science with 9-11 years of direct related experience.
  • Master's degree in life science with 6-9 years of direct related experience.
  • PhD in life science with 4-6 years of direct related experience.
• Managerial experience of ≥5 years managing a team of associates is preferred.
• Must be able to work full-time and the occasional nights and weekends

Knowledge, Skills, Abilities

• Strong knowledge of mammalian cell culture for protein expression (CHO and other eukaryotic expression systems).
• Routine wet chemistry (preparation of buffers and solutions, weighing/use of balances, formulation preparation/mathematics, pH usage/storage/calibration, fume hood operation, etc.)
• Proper aseptic technique and sterilization/disinfection methods such as autoclave usage
• Mammalian cell culture operations/handling/procedures and concept/theory. Includes biosafety cabinet/laminar flow hood operations, transfection, plasmid design, scale up techniques/theory, clone selection and isolation, cryogenic storage, sampling techniques and pipette usage.
• Bioreactor operations/handling/procedures/development. Includes the operation of centrifuges, osmometer, peristaltic pumps, and shaker/incubators.
• Technical research using experimental assays such as microscopy, spectrophotometer, and metabolite analyzer.
• Understanding of concepts and execution of Design of Experiment (DoE) studies, Quality by Design (QbD), Failure Modes Effects Analysis (FMEA), JMP software, and the application of statistical modeling in process development and process characterization
• General knowledge of tech transfer processes and scale-up techniques
• Effectively conveys complex scientific concepts and models effective scientific communication to team members and industry colleagues by authoring publications and presenting at industry conferences or webinars
• Good knowledge of GLP, GMP, and regulatory guidance for biopharmaceuticals
• Proficient computer skills (e.g., Microsoft Office, Excel, Word, PowerPoint)
• Prepares data summaries, reports and process descriptions for process development activities.
• Develops training plans for scientists to develop in technical and leadership skills.
• Maintains detailed and accurate records by logging equipment usage, procedures and results in logbooks, Batch Records, or laboratory notebooks in accordance with GDPs.
• Actively participates in and troubleshoots general laboratory maintenance (e.g., material ordering, inventory management, record management, general housekeeping, equipment).

Physical Demands

• Appropriate levels of personal protective equipment (PPE) is required for this position.
• Frequent repeated motions such as grasping, fine manipulation, lifting, bending, twisting, squatting, crouching, kneeling, sitting, crawling, reaching, climbing on step stools, and reaching is required. Repetitive use of arms/hands/wrists and visual acurity is required. This role may also require unassisted lifting (not to exceed 50 lbs).  
• Dynamic, fast-paced, interactive, and entrepreneurial environment 

Work Environment

• The position is based indoors, and the individual will primarily be working with others, but also independently.  This position will work in both an office space and lab space. 
• The position is a team and project-based position that will require occasional shift work, weekends, evenings, and holidays.
• This role may be exposed to dust, mist, fumes, chemicals and allergens.

Supervisory Responsibilities 

This position is a direct people manager responsible for:

• Driving the completion of financial business drivers (milestones, revenue generation, innovation).
• Contributing to the design of the company strategy and vision.
• Leading and building a department comprised of scientist and associate teams.
• Facilitating and leading training of new employees     

 Travel

This position requires up to 10% of travel.

Target Bonus

16%