Job Descriptions in Operations, Process/Product Development, Manufacturing and Production and Environmental Health & Safety
Vice President of Operations
Job Description
Has overall responsibility for pharmaceutical product development/technology transfer and product manufacture according to Food and Drug Administration (FDA) guidelines, Good Manufacturing Practices (GMP) and ISO 9000 requirements for clinical trials of Investigational New Drugs (IND) and approved New Drug Applications (NDA) materials. Identifies personnel needs, trains, develops and motivates subordinates in product development, plant operations, facility maintenance, process and equipment validations. Is responsible for optimizing production of existing products manufacturing; assuring compliance with GMP and National Regulatory Commission (NRC) regulations; operations budget including capital requirements; improving productivity of the vial inspection process; facilitating technology and manufacturing process transfer; providing product for applicable clinical trials as required to support US NDA file; and supporting program development as appropriate to decisions regarding market opportunities.
Education/Experience
Requires PhD in engineering or other scientific discipline, 10-12 years' experience or MS in engineering and 15+ years' management experience.
Director of Product/Process Development
Job Description
Directs the development, planning and implementation of product and process development for new products and technologies from the laboratory through pilot plant and manufacturing scale. Provides strategic direction, tactical oversight and technical expertise for all activities within the Product/Process Development area. Oversees production schedules, materials, equipment and manpower requirements. Formulates and recommends manufacturing policies and programs to maximize yields and reduce costs. Develops budgets for labor and capital expenditures. Represents departmental activities as needed, including project teams, task forces, audits and business or technical meetings with outside groups.
Education/Experience
Requires PhD in Chemistry, Biochemical Engineering, Biochemistry, Microbiology, or a related discipline with 7-10 years in all aspects of process/product development, or BS/MS degree with 12+ years of relevant experience. Experience with cGMP, GLP, process development/scale-up and methods/process validation is preferred.
Process Development Supervisor
Job Description
Supervises one or more of the functional areas (such as fermentation or purification) within process development with responsibility for designing and scaling-up production processes from laboratory scale through pilot plant scale, and transferring production processes to the manufacturing department. Plans and implements the development of new process formulas, establishing instrument and operating equipment specifications and improving manufacturing techniques to maximize product yield and reduce manufacturing costs. May act as liaison with Research and Manufacturing to ensure processes and designs are compatible.
Education/Experience
Requires a BS/MS and 5-8+ years of experience implementing scale-up processes.
Process Development Associate
Job Description
Responsible for evaluating, improving and scaling-up manufacturing processes in order to improve product yield and reduce overall costs of production. Executes small-to-medium scale production work, which may involve cell culture, fermentation, purification and/or chromatography. Additionally, assists with maintenance of production equipment. May research and implement new methods and technologies to enhance operations and may assist in validation of production processes.
Education/Experience
Requires a BS/MS degree in a scientific discipline or equivalent. A minimum of 2-5 years experience in the development and optimization of manufacturing processes is required with a Bachelors or 0-2 years
Process Development Technician
Job Description
Responsible for the definition, development and optimization of processes and equipment from the laboratory through pilot plant and manufacturing scale. Identifies and resolves issues with materials, processes, or equipment. Mixes compounds, prepares test samples, maintains inventory of materials on a regular basis and operates equipment as required. Executes process validation/equipment qualification processes and maintains files of lab tests, work procedures, formulations, calculations and assembly methods. Responsible for routine maintenance on all equipment used. Maintains records to comply with regulatory requirements, GMPs and standard operating procedures and assists in writing production procedures as necessary.
Education/Experience
Requires BS or equivalent in engineering or related discipline and a minimum of 2-5 years experience in process/product development preferably in a pharmaceutical or research development environment. Prior work experience with computerized instrumentation and micro measurement equipment is desirable.
Director of Manufacturing
Job Description
Responsible for the development, implementation, and ongoing support of manufacturing business systems including clinical and commercial production activities. Ensures plans and resources (people, facilities, supplies etc.) are efficiently utilized to ensure uninterrupted supply of products produced. Oversees the hiring, development, retention and optimal performance of staff for the leadership and execution of manufacturing operations. Develops comprehensive operating plans and budgets and monitors achievement of business and financial goals. Responsible for the development of effective working relationships with both internal and external partners.
Education/Experience
Requires a BS in the sciences; MS is preferred and a minimum of 8+ years of experience in all aspects of the manufacturing process in a pharmaceutical or biotechnology environment. Previous management or project experience is required and knowledge of GMP and GLP is preferred.
Manufacturing Manager
Job Description
Responsible for the production operations associated with the manufacture of all GMP products. Develops weekly/monthly goals and schedules for supervisors and manages activities through shift or unit supervisors. Oversees progress of supervisors' daily schedules to ensure safe and timely completion of releasable products. Point person for technical and compliance issues and liaisons with internal groups (QA, QC, Regulatory etc.) to facilitate issue resolution. Ensures functional unit's compliance with GMP and all its related elements such as facilities, documentation (SOPs and validation protocols etc.), training, reports and records. May be required to negotiate process-manufacturing agreements or manage external manufacturing contracts.
Education/Experience
Requires BS in a relevant science or engineering discipline and a minimum of 5-8 years experience in a biotechnology manufacturing/quality/development environment. Thorough knowledge and understanding of cGMPs and familiarity with FDA guidelines is required.
Manufacturing Supervisor
Job Description
In small to medium size companies supervises the transference of cell culture/fermentation methods from research and development to manufacturing. Supervises and maintains purification production methods, processes and operations for new or existing products. Implements and maintains production schedules and manpower requirement. Directly provides guidance to employees to ensure operations meet GMPs. Provides general supervision over a work group, assigning tasks and checking work at regular intervals. Other key responsibilities may include interacting with outside vendors and departments, scheduling validation activities, training operators, and writing/approving Maintenance Work Requests, Engineering and Facility Change Requests, and Purchase Requisitions.
In large companies, separate supervisors will be used for cell culture/fermentation and purification processes.
Education/Experience
Requires BS and a minimum of 3-5 years' experience in all aspects of the manufacturing process in a pharmaceutical or biotechnology environment. Working knowledge of cell culture, aseptic and scale-up operations in accordance with cGMPs is required.
Manufacturing Associate
Job Description
Performs a variety of complex tasks under general guidance and in accordance with current GMPs. Plays a role in implementing new technology into the manufacturing process or in starting up a new manufacturing area. Performs some or all of the following in strict accordance with Standard Operating Procedures (SOPs): fermentation, protein purification, solvent extraction, tissue culture, preparation of bulk solutions, non-critical aseptic fills of buffers, filling and labeling of vials under sterile and non-sterile conditions, large scale bioreactor operations, critical small or large volume sterile fills, aseptic manipulation of cell cultures.
Operates with minimal supervision complex systems and equipment and optimizes their use in manufacturing in accordance with defined goals. May participate in plant trials for evaluating process modifications. Troubleshoots processing problems, bringing unusual problems (i.e., potential deviations) to the attention of the supervisor. Assists in the implementation of production procedures to optimize manufacturing processes. Monitors processes and results and suggests methods to ensure process success. May attend research meetings related to the transfer process of new products. Organizes own daily workload schedule and relevant resource requirements. May provide training to new personnel in a specific technical process. Participates in authoring complex, explicit documentation for manufacturing operations.
Education/Experience
Requires AS with 4-7 years' related work experience or BS in biology or related life science and a minimum of 2-3 years' experience. Detailed knowledge of purification systems and familiarity with regulatory and Standard Operating Procedures is required.
Manufacturing Technician
Job Description
Responsible for assisting manufacturing in specific product-related operations in cell culture/fermentation. Operates and maintains production equipment as it relates to cell culture/fermentation (i.e., fermenters, bioreactors, cell harvests and separation operations). May also assist manufacturing in production-scale protein purification and manufacturing of final products. Weighs, measures and checks raw materials to assure proper ingredients and quantities. Prepares media and buffer components. Maintains records to comply with regulatory requirements and assists with in-process testing.
Education/Experience
An entry-level position requires a high school diploma, certificate in biomanufacturing, AS degree or equivalent experience plus a minimum of 0-2 years' related work experience in a manufacturing environment.
A senior-level position requires BS in biology or related life science and 1-4 years' experience.
Manufacturing Instrumentation / Calibration Technician
Job Description
Maintains, tests, troubleshoots and repairs a variety of circuits, components, analytical equipment and instrumentation. Calibrates instrumentation and performs validation studies. Specifies and requests purchase of components. Analyzes results and may develop test specifications and electrical schematics. Performs continuous monitoring of equipment status, condition and location. Prepares required documentation for the recording and notification of events and changes related to equipment such as calibration certificates, deviations, out of tolerances and installation reports.
Education/Experience
Requires an AS in electronics technology or equivalent technical training related to mechanics or instrumentation and a minimum of 2-4 years' experience with instrumentation, problem diagnosis and repair. Knowledge and understanding of measurement parameters and experience working in a GMP environment is preferred.
Material Handler
Job Description
Responsible for the collection and distribution of materials between departments and the shipping department. Wraps and protects materials for safe transportation or warehouse storage. Loads and unloads materials on/ from freight vehicles, and stacks items in inventory. Other responsibilities may include lifting heavy loads (in excess of 70 lbs), operating a forklift, inspecting received goods, performing inventory reconciliation, updating inventory databases, weighing and dispensing materials for manufacturing.
Education/Experience
Requires a high school diploma or equivalent and a valid driver's license. Forklift experience and the ability to lift heavy loads is desirable.
Purchasing Agent / Buyer
Job Description
Responsible for planning, organizing, directing and controlling purchasing activity for all production and non-production related goods and services required to support the manufacturing plant. Purchasing activities include supplier selection and the negotiations with suppliers for price, quality, timeliness of delivery, specifications, value improvement programs, contract administration, requisition review, and purchase order execution. Other responsibilities include maintaining knowledge of market conditions and advising management on purchasing alternatives to assure a continued flow of materials to meet production and sales requirements.
Education/Experience
Requires BS in Business, Material Management or related field with a minimum of 3 years experience in a purchasing and/or materials environment. Effective negotiation, persuasion and communication skills are also required.
Aseptic Fill Supervisor
Job Description
Supervises all aseptic filling activities in accordance with GMPs, GLPs and SOPs regulations. Areas of responsibility include equipment/component preparation, sterilization and sanitation of aseptic filling rooms. Manages work group, assigns tasks and checks work. Reviews and processes Batch Production Records. Additional responsibilities include hiring, developing, and overseeing the training of new employees.
Education/Experience
Requires BS in Biology, Chemistry, or related area plus a minimum of 3-5 years of supervisory experience in a pharmaceutical environment preferably in aseptic filling.
Aseptic Fill Research Associate
Job Description
Implement production procedures to optimize the aseptic fill manufacturing processes in accordance with GMP regulations. May assist process development in developing scalable processes to improve yield and reduce cost for aseptic fill manufacturing systems. Other responsibilities may include filling, labeling and packaging of products, or the operation/maintenance of production equipment.
Education/Experience
Requires BS in a scientific discipline or equivalent and a minimum of 0-2 years' experience in an aseptic fill, manufacturing environment.
Aseptic Fill Technician
Job Description
Assists in the operation and maintenance of production systems. Other responsibilities may include setting up, changing-over and operating labeling and packaging equipment.
Education/Experience
Requires a BS in a scientific discipline for senior-level positions or an AS or certificate in Biomanufacturing for entry-level positions and a minimum of 0-2 years' work experience in an aseptic fill manufacturing environment. Knowledge of manufacturing procedures and federal regulations pertaining to manufacturing processes is preferred.
Facilities Manager
Job Description
Manages the design, planning construction and maintenance of equipment, machinery, buildings and other facilities. May have responsibility for health and safety standards. Plans, budgets and schedules facility modifications including estimates on equipment, labor, materials and other related costs. Oversees the coordination of building space allocation and layout, communication services and facilities expansion.
Education/Experience
Requires BS or equivalent and a minimum of 5 years' experience in maintenance trades and knowledge of building codes.
Facilities Technician
Job Description
Performs daily monitoring, repair, and preventative maintenance activities on critical systems and facility equipment. Also troubleshoots, install and modernizes new and existing systems, including refrigeration equipment, water systems, HVAC systems, and electrical systems. Documents repairs, adjustments, and replacement of equipment and/or components per GMP standards. May also provide input and corrections to Standard Operation Procedures (SOPs) and assist engineering in the evaluation of new equipment or technology.
Education/Experience
Requires an AA/AS or Certificate of Completion at a 2-year technical school in the mechanical/electrical field or a high school diploma with 5+ years of experience in GMP maintenance. Knowledge of major trades, such as carpentry, electrical, plumbing, and HVAC/refrigeration including the ability interpret blueprints, technical manuals and specifications are required. Experience in a pharmaceutical or bio pharmaceutical environment is preferred.
Shipper/Receiver
Job Description
Responsible for loading or unloading, checking, storing, moving and recording the movement of supplies, raw materials, equipment and products to and from internal departments, external suppliers and/or customers. Other responsibilities include preparing bills of lading, invoices, requisitions and other documents, routing shipments, reviewing receipt of all materials and verifying quantities, and ensuring outgoing shipments are packaged according to specification.
Education/Experience
Requires a high school diploma or equivalent. Previous experience and knowledge of shipping and couriers is a plus. A valid driver's license may be required for some positions.
Toxicologist
Job Description
Designs and oversees regulatory and investigative toxicology studies in support of product registration based on innovative drug delivery technologies. Participates in the review and assessment of products and initiates any needed testing. Provides interpretation and consultation in regard to safety data, and direction and guidance for managing risk assessment support programs. Prepares toxicological/human safety assessments pertaining to occupational, consumer and environmental exposures derived from manufacturing processes and product usage. Participates on internal committees/teams on product stewardship, product risk characterization and regulatory affairs matters. Tracks and monitors existing and pending legislation/regulations and serves as a representative on external trade and scientific associations.
Education/Experience
Requires an MS or Doctorate (PhD, MD or equivalent) in toxicology, biological sciences, or related health science field, and a minimum of 1-5 experience in toxicology studies. Working knowledge of US EPA regulations, international regulatory toxicology operations and a broad knowledge base in pharmacology of biotechnology products is highly desirable.
Environmental Engineer
Job Description
Responsible for the research, coordination, implementation, and management of environmental issues including waste disposal, air/water quality, pollution control, hazardous waste, and land management. Prepares permit applications and performs environmental regulatory reviews. Performs periodic inspections of facility operations, participates in reviews of other facilities' environmental activities and participates in environmental audits. Develops and maintains appropriate documentation to assure compliance with governmental regulations. Additional duties include the development and management of programs to meet regulatory requirements, including corrective actions, monitoring and reporting to environmental agencies when required.
Education/Experience
Requires a BS in Environmental, Civil or Chemical Engineering, or related discipline, MS is preferred, and a minimum of 3-5 years' environmental engineering experience. Thorough knowledge of engineering documentation including expertise in permitting, pollution prevention, environmental regulatory compliance, training and reporting is required. Experience working in a GMP facility is desirable.
Environmental Technician
Job Description
Responsible for water and air sampling and monitoring, processing permits, calibration and maintenance of scientific monitoring, data collection, and routine analysis. Installs and services recording instruments; maintains physical stations where data is collected, inspects stations records to ensure quality assurance and preventative maintenance procedures are conducted properly. May conduct special studies such as toxic water monitoring, biological monitoring, and air/water pollutant investigations and recommend corrective actions. Records and maintains periodic data logs and information files. Typically works from drawings, specifications, diagrams, schematics and specific verbal and written instructions.
Education/Experience
Requires a high school diploma with some specialized or technical training in environmental sciences, chemistry, math, hydrology, ecology, toxicology or a related field. A two or three year community college program in environmental technology is preferred. Working knowledge in sampling, data collection and analysis, pollution complaint investigations, instrument calibration, environmental law or experience in assessing environmental conditions is desirable.
