Manager of Technical Operations:

 SUMMARY:

The Manager of CMS Manufacturing is responsible for all activities and leadership associated with the CMS-M Technical Operations group. Support Product development, Process Engineering, Scale up, Process Validation, and Stability activities as mandated by cGMP’s policies/procedures and quality standards.  Assist Operations and Quality units as necessary.  Assist Project Engineering staff for facilities design and equipment qualifications.  Manage and coordinate CMS Associates, Technicians, operations and quality personnel during development, validation and scale-up activities, as necessary.  Works closely with CMS-C, Operations, Quality and Marketing.  Represents CMS-M at meetings.  Ensures compliance with all aspects of operations.

EDUCATION AND/OR EXPERTISE:

Advanced degree preferred in Pharmacy, Pharmaceutical Sciences, Chemical Engineering or related disciplines, with a minimum of 10+ years related experience and/or equivalent combination of education and experience in Pharmaceutical Development/ Manufacturing. Experience with development of modified release technologies including matrix and pellet formulations is required. Working knowledge of manufacturing equipment and/or minimal formulation knowledge is required. Excellent oral and written communication skills required. To perform this job successfully, an individual must be proficient in each essential duty and the ability to work with minimum supervision. Thorough knowledge of analytical laboratory testing, regulatory filing requirements and the impact of guidances in streamlining the technical / process operations. Prior experience in managing groups is essential.

Sr. Process Engineer:

SUMMARY:

The Sr. Process Development Engineer designs, implements and optimizes manufacturing/production processes, instrumentation and equipment, from lab through pilot plant to production scale-up to meet product and process design specifications. Implements Quality by Design, Quality Risk Management, and Life Cycle Management on assigned products.  Displays the leadership and technical skills necessary to lead projects with limited supervision. Identifies and introduces new technology and tools into development or commercialized product applications. Interfaces with external CRO/CMO organizations and also with internal technical groups (Formulation, Chemistry, Analytical, Quality) to facilitate rapid and efficient tech transfer activities. Contributes to the development of specifications of raw materials, drug product and packaging components. Supports CMC related activities for regulatory submissions.  Supports Operations for trouble shooting.

EDUCATION, SKILLS AND EXPERIENCE: 

BS degree or higher in Mechanical or Chemical Engineering. 10+ years experience in a regulated pharmaceutical environment coupled with equipment and processes utilized to manufacture pharmaceutical products. Thorough working knowledge of production unit operations and validation principles. Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required. Excellent interpersonal effectiveness and communication skills (written and oral). Extensive cross-functional team experience. This position requires strong analytical skills, hands-on troubleshooting skills. Proficient in general computer applications such as, MS Word, Excel, Outlook, etc. and other applicable applications as required e.g. JMP®, etc. Send resume and salary information to: wnt@talbotassociates.com

Sr Chemical Process Engineer:

 Our international client has an immediate opening for a senior process engineer with pharmaceutical experience.  Qualifications:  Minimum of a BSChE, pharmaceutical manufacturing experience, scale up, R&D, pilot plant, validation, specifying process equipment, supervisory experience, hands-on process improvement, must come from an operating plant background (not consulting), minimum of seven years experience, be will to relocate, if necessary, to a Midwest cosmopolitan area.  Forward CV to wnt@talbotassociates.com. 

Plant/Site Manager:

Our client is an international corporation.  We have an immediate need for an experienced plant and/or site manager with pharmaceutical experience.  This plant is experiencing excellent growth and the new manager will need to have the demonstrated skill and experience to meet the challenge of sustaining and stimulating this growth.

This is a golden opportunity for the entrepreneurial type of manager.  The manager must be able to operate independently reporting to a remotely located regional VP.  Qualifications:  BS degree in sciences.  Engineering academic background with a MBA would be strongly preferred.  Minimum of 8 years experience demonstrating increased management responsibility in the area of  chemical/pharmaceutical plant process operations.  Strong leadership, communications, and a team managing attitude are essentials.  Must be willing to relocate to a Midwest location.  Send CV to wnt@talbotassociates.com.

Senior Formulation Scientist

A well established nutraceutical company is looking for senior formulation scientist to design and formulate unique, new or improved solid dosage products.

Qualifications:

            -Minimum BS in Chemistry (MS or PhD preferred)

            -5-7 year’s product development experience

            -Formulation experience in solid dosage dietary supplements

            -Ideation and innovation of products

            -Strong communication and interpersonal skills

Please forward resume to kpd@talbotassociates.com.

                                              Process Engineer

The following is a partial description of the process engineer’s responsibility:

The process engineer will work within the process engineering department and will report to the process engineering manager.  This individual will be responsible and capable of providing process design engineering activities for strategic capital and operational improvement projects.  Additionally, the person will provide engineering assistance for the purpose of transferring new systems, and the technology related to them, to manufacturing. 

The individual, as directed by the manager, will serve with project teams and be responsible for process engineering activities from the development of the preliminary

engineering file through to equipment start up and operational qualification. 

The process engineer must have demonstrated skills to be able to work with all departments including manufacturing, quality assurance, R&D, and the project engineering group in the development of flow diagrams, specifications, P&IDs, and process descriptions. 

This individual will have the skill to coordinate internal projects with outside engineering vendors when required, and will be able to commission and qualify the installation of systems. 

The process engineer will assist the manager in the development of cost estimates and schedules for use in the control and authorization of projects.

 Individuals applying must have a Bachelor of Science degree in Chemical Engineering.  A five year history of process engineering within a pharmaceutical environment is essential.  A working knowledge of solid dosage drug applications such as granulation, tablet essentials, filling, coating, etc. would be strongly preferred.  The person will have demonstrated ability to troubleshoot manufacturing process problems and a working knowledge of GMP applications.  Good computer skills are essential.  Strong interpersonal skills as well as verbal and oral communication skills are necessary.

        Pharmaceutical Process Engineering Manager

The process manager will report directly to the director of engineering.  In this role the manager will have the competency to be able to apply pharmaceutical experience in engineering techniques and principles to develop, specify, and implement product manufacturing processes for the company’s new drug applications, as well as making recommendations for the improvement of processes that can favorably affect the quality and efficiency of existing product manufacturing operations.   

The manager and the department will work in conjunction with all other departments, when required, in issues related to processes associated with the development or manufacture of products.  This includes providing on going process technical support to manufacturing facilities for problem solving, issue resolution, and process improvement.  Effective process design and assistance in scale up experiments in labs, pilot plant, and production will be provided by the manager and the process department.  These activities are achieved in a team environment and in a collaborative manner with all of the staff who are involved with the task of bringing new products to the marketplace.  This individual will have the ability to work on the production floor with manufacturing and maintenance personnel to troubleshoot processes and provide engineering expertise to implement solutions.

The manager will accomplish the department objectives through the effective direction of those who are selected to be members of the process department team.  The manager is responsible for the direction of the department including hiring, orienting, training, supporting, assigning, scheduling, coaching, counseling, and disciplining employees; communicating job expectations, planning, monitoring, appraising, and reviewing job contributions, as well as reviewing compensation actions and enforcing company policies and procedures.

The manager will function within the company financial objectives and budget, and will render assistance to that goal by forecasting department requirements, scheduling expenditures, analyzing variances, and initiating corrective actions.  This individual will have the ability to work with all departments to develop the flow diagrams, mass balance, specifications, P&IDs, process descriptions, preliminary file (basis of design), equipment selection/design, start up, and operational qualification.

The manager will complete product and process projects by developing specifications, planning and monitoring milestones, monitoring results, adjusting actions, and advising on implementation.

The manager will make every effort to insure confidentiality related to company products and processes and most especially as it relates to the development of new products and technology.

The manager will insure that a safe, secure, and healthy work environment exists for his department by complying with all regulations.  The manager will also make every effort to create a work environment that encourages creativity, enthusiasm, open communication, project ownership, independent thinking, self improvement and development, and a team attitude.

 A candidate will have a bachelor’s degree in chemical engineering and a (strong preference) a master’s degree in chemical engineering, or a closely related field of master’s study.  At least ten years in pharmaceutical process engineering, demonstrating a progression of responsibility leading to management experience with direct reporting subordinates.  

 Experience should demonstrate a broad knowledge of pharmaceutical process development, experience with IND and NDA, solid dosage process knowledge, and  manufacturing process applications.  Background should include experience with process development, scale up, and technology transfer.  This person must also have strong leadership skills coupled with excellent verbal and writing communication ability.