Thermo Fisher Scientific Senior Lead Manufacturing Operator in Bend, Oregon

Job Description

Job Title: Senior Lead Manufacturing Operator

Summary:

Supervises and performs clinical trial manufacturing at the Oregon Regional Patheon Development Services (ORP) site.

Essential Functions:

Provides leadership to assigned staff by performing the following:

leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.

Leads, engages, motivates, and supports the team to meet the daily manufacturing plan.

Executes and monitors manufacturing operations including procedures, batch records, and components to ensure that current Good Manufacturing Practices (cGMP) requirements are met.

Coordinates with technology transfer engineer and materials team to ensure manufacturing readiness is achieved on time.

Trains personnel on cGMPs, manufacturing techniques, procedures, batch records, and associated forms. Trains personnel on manufacturing and facilities equipment setup, operation and maintenance.

Ensures documentation of training is complete and accurate for all assigned personnel.

Coordinates with the facilities team and validation engineer to maintain operability and maintenance of manufacturing equipment and facilities.

Assists in creation and maintenance of the Daily Production Schedule and individual personnel assignment schedule.

Assists in preparation and pre-approval review of Master Batch Records.

Reviews Production Batch Records and submits for Operations and Quality Management approval.

Performs administrative responsibilities with direct reports (responds to time off requests, approves time cards, etc.). Conducts regular one-on-one meetings with direct reports and supports the performance management process.

Job Scope:

Provides tactical direction and immediate supervision to a group of employees by assigning tasks, checking work, and maintaining schedules. Erroneous decisions or failure to achieve results will add to costs and may impact the short-term goals of the company.

Supervision:

Provides direct supervision and may assist with the work as demands dictate.

Education:

Associates Degree required, Bachelor’s degree in science or related field preferred.

Experience:

Five years of cGMP production experience in the pharmaceutical or nutraceutical industry preferred.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

Good knowledge of cGMP production experience in a pharmaceutical or nutraceutical dosage forms manufacturing setting preferred. Experience manufacturing Solid Dosage forms (tablets, capsules, granules) strongly preferred.

Knowledge of cGMPs (CFR.210/CFR.211), manufacturing equipment assembly, operation, and cleaning. Ability to train personnel on conduct of operation tasks and applied cGMPs required. Strong mechanical aptitude, time-management, and shift planning. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Effective written and interpersonal skills. Leadership position requiring supervision and development of personnel preferred, such as the ability to drive functional, technical and operational excellence. Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.

Physical Requirements:

Work setting: Production of pharmaceutical dosage forms in a small-scale manufacturing suite setting. Position requires frequent standing (up to 8 hours) as well as ordinary ambulatory skills and physical coordination sufficient to move about office, laboratory & manufacturing locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of medium to heavy weights of 35-50 pounds; arm, hand and finger dexterity, including ability to grasp and move for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate laboratory equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Please take note that we require a negative drug screen, administered by our third-party vendor, as a condition of employment.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.