Supervisor Technical Operations

Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.

Working at Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning.

A s the Senior Supervisor Technical Operations, you will be Responsible for providing technical support to the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).

Understands aseptic technique concepts

Monitors overall performance of aseptic technique ensuring compliance with standards

Identifies aseptic technique gaps and opportunities and implements improvements across assigned programs

Understands basic operations and functions of equipment

Understands the corrective/preventative maintenance and calibration of equipment

Works with vendor to understand and resolve issues

Understands basic solution and material preparation

Trains, coaches, mentors and manages performance of others performing solution and material preparation, analyzing results and resolving issues

Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy

Trains, coaches and mentors others in technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy

Possesses basic and fundamental engineering and mechanical knowledge and is able to apply in the manufacturing area demonstrating unit operational and end-to-end understanding

Trains, coaches, and mentors others with engineering and mechanical knowledge and how to apply to manufacturing area for unit operations and end-to-end understanding

Ideally, possesses basic and fundamental facility start-up experience

Ideally, trains, coaches, mentors others on facility start-up

Ideally, has participated in facility start-ups and may lead a subteam that requires leading, planning, coordinate, delegate and manage across assigned programs

Ideally, provides input into facility design

Trains, coaches, mentors and manages performance of technical transfer activities

Reviews protocols and provides input on other technical transfer documents

Understands the application of GMP concepts as the process develops during phases of technical transfer

Trains, coaches, mentors and manages performance of validation activities

Provides input and review validation documents

Has working knowledge of validation requirements

Identifies validation gaps and needs across assigned programs

Possesses basic and fundamental understanding of material related activities and execution

Subject Matter Expert (SME) on Master Control

Internal SME on some support systems (e.g. LIMS)

Trains, coaches, mentors and manages performance of others use of support systems

Acts as lead, member or Champion that helps to design the new system or of a systems improvement team

Understands the concept of and has performed or experience with manufacturing processes and methods

Trains, coaches, mentors and manages overall performance of manufacturing processes and methods ensuring compliance with standards

Possesses manufacturing end-to-end operational expertise

Identifies, participates, understands and able to explain the 'why' of acceptable and unacceptable practices; is able to make suggestions with options and recommend path forward and leads basic sessions to improve performance

Understands processes and recommends product/lot impact

Identifies process and method gaps and opportunities and implements improvements across assigned programs and site specific and teaches, coaches, mentors and manages performance of others to do the same

Performs basic and complex analysis, interprets, and draws conclusion of scientific and process data per good document practices

Communicates with internal and external stakeholders scientific and process data and recommends path for forward processing

Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands 'why' behind the regulations. Able to train, coach, mentor and manage performance of others to do the same

Identifies, communicates, addresses and improves complex cGMP compliance and regulatory gaps and issues across assigned programs and site specific

Follows and executes Standard Operating Procedures (SOPs)

Trains, coaches, mentors and manages performance of others who execute SOPs

Revises, authors and reviews simple and complex SOPs

Standardizes and aligns SOPs

Improves the efficiency and execution of SOPs

Reviews and approves SOPs Qualifications

HS Diploma or equivalent required and 7+ years relevant technical experience and min 3 years in a Lead/Leadership/Supervisory Role

BS/BA in Science related field preferred; or combination of relevant Experience & Education Knowledge / Skills / Abilities:

Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.

Clarity of vision at near and mid-ranges (less than 20 feet), depth perception and ability to identify and distinguish colors.

Must be able to work in Lab setting with Biohazards /various Chemicals

Must be able to wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE).

Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards (i.e. vacuum pumps, pressurized vessels), dangerous materials (i.e. chemicals, solvents, pathogens), freezer burns, allergens and strong odors.

Based on work assignment, may be recommended to have medical testing in accordance with the company's Occupational Health Program.

Holiday and shift work often required based on manufacturing schedule as determined by Management.

Proficient in Oral & Written communication skills Advanced Therapies

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, or protected veteran status and will not be discriminated against on the basis of disability."

Permanent