Plans, administers and technically directs occupational health and safety activities and staff.
Responsible for providing occupational health and safety practices, procedures, programs and projects affecting personnel, facilities, equipment, materials and environment. Responsible for reviewing and incorporating health and safety standards promulgated by local, state and federal regulations, as well as customer requirements, into AFC programs. Recognize, evaluate and recommend measure for control of chemical, safety, and physical hazards at the work site. Maintain in-depth knowledge of existing and proposed changes in industrial health and safety regulations and legislation. Develops AFC health and safety training programs. Provides short and long range planning for health and safety operations and implements approved plans. Assures that activities within defined scope are accomplished in accordance with AFC policies, sound business practices and are in compliance with applicable regulations and requirements.
Skills and Knowledge:
|●||Ability to provide effective direction, leadership and team building.|
|●||Skills and abilities to provide technical and administrative guidance for activities in defined scope of responsibilities.|
|●||Ability to communicate effectively, both verbally and in writing.|
|●||May require the understanding and/or use of chemical processes and manufacturing equipment.|
|●||Knowledge of industrial hygiene and safety principles, theories, concepts and techniques.|
|●||Provides technical and administrative leadership on technology issues and concept definitions critical to the maintenance of AFC business posture. Advises subordinates in the resolution of health and safety technical and operational problems.|
|●||Establishes operational policies which affect subordinate multi-level functional groups. Interprets, executes and recommends health and safety policy changes.|
|●||Manages allocation and integration of department resources to meet commitments and objectives.|
|●||Submits and administers operational budgets and schedules for health and safety programs.|
|●||Advises management as to integration of industrial health and safety efforts with those of AFC.|
|●||May be responsible for conducting audits and evaluations to determine health and safety program effectuation.|
|●||Coordinate and manage health and safety function interface with regulatory agencies and customer representatives. Maintains frequent contacts with inter-organizational managers and with regulatory agencies. May act as coordinator for regulatory inspections and audits. CFATS regulations desirable but not required.|
Requires a Bachelor's Degree and 7 to 9 years directly related experience in an appropriate discipline/science or equivalent combination of education and experience. Requires demonstrated supervisory skills including the ability to plan and coordinate the activities of assigned organization. Ability to provide technical and administrative leadership to accomplish organization goals and commitments. Manufacturing / Production environment experience highly desired.
Under general direction, performs quality-engineering assignments requiring a wide application of advanced quality principals, theories and concepts including a working knowledge of pharmaceutical manufacturing operations. Provides imaginative, thorough, and practicable solutions to a wide range of technical problems involving conventional utilization of quality engineering techniques. Review engineering designs and specifications. Will review and assist in equipment, process, cleaning and computer validation efforts working with experienced process engineers. Prepare and review protocols, SOPs and other quality documentation. Offer solutions for improvement. May prepare and perform personnel training.
Should have knowledge of, and ability to, understand the following: ICH-Q7A requirements for API's, 21 CFR cGMP regulations, USP, EMEA and other international regulations. Ability to read and understand P&IDs, as built drawings, process flow diagrams and other engineering records is needed. Must have some experience using typical quality engineering methods for analysis of data including control charts, variability statistics, DOE methods, variance analysis, process capability indices. Six Sigma, DMAIC and lean tools are all a plus.
Must have experience writing, reviewing, executing and summarizing data from qualification and validation studies. Must have experience with IQ/OQ/PQ of equipment and utilities. Experience with process control or other automated systems a plus. Must understand Process Validation and Cleaning Validation concepts and procedures. Exposure to ISPE guidelines is helpful. Computer skills must include MS-Office. Use of MS-Project, Visio, AutoCad or xView will be helpful. Understanding of GDP, and document control requirement is desirable as well.
Bachelor's degree in chemical, mechanical, manufacturing or process engineering desirable. Two to six years' experience in an FDA regulated environment or a combination of education and experience. Strong knowledge of process industries, chemical processing, manufacturing processes, computer equipment validation, and product/process validation. Knowledge of quality engineering principals, analytical and problem solving skills. Excellent communication skills. Ability to participate in and contribute to cross-functional teams. Good knowledge of cGMPs, 21 CFR 210, 211, 11, FDA regulations, ICH Q7A. Knowledge of quality-related databases and software systems. Some knowledge of chemistry required. Knowledge of industrial safety requirements.
Candidate will plan and execute independently assigned tasks such as method development, transfer and validation; provide analytical support to the research and development group to meet project goals; select appropriate methods and techniques in performing experiments; collaborate with senior personnel and/or manager to develop routine analytical methods; work cross functionally to achieve target goals; proactively seek out potential solutions to issues; attend project meeting to assure that all client analytical requirements are met; serve as a resource to other researchers involved in project.
Assure a positive transition of developed and validated methods to the quality control department personnel; conduct peer review and method approval. Candidate will also be responsible of creating method validation and/or qualification protocols and reports as well as analytical methods; perform all lab work that will support method validation, transfer, and qualification; perform qualification of primary and secondary reference material to be used as analytical standards.
Must have knowledge of ICH guidelines in method validation. Must understand the requirements for methodology transfer.
Requires a BS in Chemistry or related field, and at least 4 years experience in method development/validation/transfer, or an MS and at least 3 years of relevant experience in a cGMP environment; strong interpersonal and verbal communication skill; the ability to excel in a team-oriented environment and to use common tools for effective scientific communication within the company. Knowledge of the following instrument is required but not limited to: LC/UV/DAD/MS, FTIR, GC, GC/MS, NMR, and KF.
|●||Responsible for development and implementation of the PSM Program in accordance with the standards noted in California Code of Regulations, Title 8, Section 5189 and the California Accident Release Prevention (Cal-ARP) Program in accordance to Title 19 Div. 2 Chapter 4.5 (Cal-ARP).|
|●||Candidate must be capable of facilitating hazard reviews, managing the 13 elements in the PSM program, the non-PSM elements of the Cal-ARP program, and conduct off site consequence analyses for compliance with the Cal-ARP program.|
|●||Requires interfacing with other departments to effectively manage the on site inventory of regulated materials below the threshold quantities where feasible to minimize on-site and off-site risks.|
|●||This position will interface closely with EH&S for technical policy direction to ensure process hazards analyses are conducted for all affected processes and to lead and direct implementation of the 13 elements of the PSM program and additional elements required for Cal-ARP.|
|●||May require coordinating with outside contractors to design and implement the standards; will require lead hazards analysis teams for processes and facility design reviews. Will be required to develop and maintain action plans for PHA findings; establish processes to insure completion of required training and inspections. Will provide leadership of, and participation in, incident investigations to ensure root cause determination and document corrective action plans to ensure action plan completion, and audits to ensure compliance with the PSM standard.|
BS Degree in Engineering or Science discipline. Must have knowledge in application of PSM and Cal-ARP regulations in a chemical or pharmaceutical plant. Strong computer and database management skills. Excellent communication ability. Must be able to walk around chemical manufacturing plant and conduct audits and ensure effective implementation of this regulation.
Develop or implement new synthetic routes for drug intermediates and API's from lab scale procedures. The person should also have experience in synthesis and scale-up of polymer chemistry. Experience should include knowledge of emulsion polymerization (thermosets and thermoplastics). Develop these processes into robust and scalable processes for cGMP manufacturing. Function as a lead for the chemical development of these programs that can be scaled-up to plant scale. Maintain records of technical findings and write progress reports. Perform lab and kilo-lab demonstrations as well as support pilot lab/plant production. Provide technical support on as needed basis. Interact with internal (engineering, QC, QA, etc.) and external customers. Evaluate in-process samples via analytical techniques. Provide marketing/business development support as needed.
A Bachelor's of Science Degree in chemistry with 10+ years of experience, a Master's Degree in Organic Chemistry with 8+ years of experience or a PhD in Organic Chemistry with 6+ years experience is needed. Candidate should possess a good knowledge of organic and polymer chemistry and have a strong desire to work in lab/plant environment. Knowledge of cGMP, plant operations, and scale-up is required. Good communication skills and ability to work in a team environment with people from different disciplines is a critical requirement. Working knowledge of continuous processing is a plus. Experience in polymer industry with experience in scale-up of polymer processes to plant scale is a plus.
NMR, HPLC, GPC, Viscometer, LC-MS, GC, KF, DSC, TGA, FTIR, POLARIMETER.
Join us at:
Boston, MA - USA
July 14-17, 2013