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Supervisor, Manufacturing-Bulk Job in Wilmington, Ohio US

Supervisor, Manufacturing-Bulk

Alkermes, Inc. - Wilmington, OH

Posted: 5/10/2021 - Expires: 8/8/2021

Job ID: 227126658

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Job Description

GENERAL DESCRIPTION:

This position will provide direct leadership on the assigned shift in the manufacture of commercial product. Manages multi-disciplined teams in a pharmaceutical production area to ensure all manufacturing systems, production processes, equipment and final pharmaceutical product meets or exceeds Alkermes manufacturing standards, regulatory requirements and business objectives.

KEY DUTIES:

Acts functionally as the operational leader on the floor during the assigned shift with direct responsibility for Manufacturing Associates and operations executed by that shift

Provides effective, 'hands-on' leadership to the production team as a whole

Accountable for "in the room" operations and personnel for their assigned shift (safety, reliability, operability)

Plans and supervises daily execution of tasks to support published production plan and supervises completion of work

Communicates plan and leads shift effectively

Supports the Manufacturing Manager by complying with identified responsibilities and expectations (RACI - Responsibility, Accountability, Consultation and Information)

Ensures robust and timely communication of defined operational/planning activities associated with the execution of daily production

Readily adapts to and supports change to meet plan

Provides Manufacturing Manager with operational detail and planning as required to comply with production planning and to support Manager's initiatives

Drives/Writes/Approves new SOPs, batch records, and/or protocols in support of equipment and manufacturing processes associated with the assigned manufacturing area

The direct interface with support groups, including Facility and Process Maintenance, Engineering, Quality Assurance, Quality Control, Planning, Warehousing and Process Development, to ensure the operational status of the manufacturing area in support of published production schedule

Supports quality investigations, continuous improvement efforts and Engineering, Maintenance, Quality Control, Quality Operations activities as they directly impact the functionality of the manufacturing area

Initiates appropriate action when process deviations occur, authoring investigations when required, to ensure the timely release of product and/or continuity of operation of the manufacturing line

Ensures compliance with cGMP in the manufacture of products

Ensures maintenance and upkeep of the facility and process employed within the area of responsibility

Develops and evaluates employees

In conjunction with Manufacturing training support, ensures opportunities for training for new and current operators

Ensures qualification of operators, consistent with SOPs, to support cGMP manufacturing of pharmaceutical product

Participates in establishing expectations and goals for individuals and for team; Provides regular feedback and ensures accountability

Ensures all direct reports have clear goals, and meets with them regularly to review the goals and redirect work as needed

Conducts performance review process for direct reports

Fosters team environment through regular communication and conflict resolution

Responsible for safety compliance for assigned shift

Technical writing skills in support of daily operations and personnel management processes

SKILLS/ABILITIES:

Demonstrated experience leading/supervising employees in a pharmaceutical manufacturing environment comparable to the proposed manufacturing area

Demonstrates advanced skills particularly in operational planning, product/process impact, personnel management, multi-tasking, delegation and interpersonal relationship building

Thorough knowledge of and experience in a manufacturing environment operating under cGMP

Advanced knowledge of the Scientific Method

Advanced knowledge of and adherence to current GMPs

Basic knowledge of chemistry, biology, math, steam/dry heat sterilization theories

Basic knowledge of HAZCOM, RCRA and other Safety requirements

Demonstrated mechanical aptitude

Ability to operate all types of production equipment (i.e. various manual valves, automation panels, parts washer, glovebox, etc.)

Able to comply with procedures for gowning in controlled or aseptic areas

Ability to lift/move 50 lbs. overhead (team lift 100 lbs.)

Excellent verbal and written communication skills; detailed-oriented

Excellent documentation skills

General knowledge pharmaceutical finished product manufacture standards

Ability to read, understand and accurately follow company SOPs and guidelines

Ability to interview, hire and develop personnel

Must be able to accomplish assignments on time

PERSONAL ATTRIBUTES:

Leadership-oriented

Team Player committed to quality and working effectively with others

Motivated self-starter

Detail and results oriented

Dependable

Well organized

Efficient worker with good communication skills

Willing to learn new tasks, skills

Readily adapts to changing job duties

Positive attitude

Displays understanding of and promotes company and customer objectives

EDUCATION AND EXPERIENCE:

5 years experience in regulated industry, preferably in cGMP pharmaceutical manufacturing or development environment

Minimum of 3-5 years of supervisory experience

AS/BS degree in Engineering, Scientific Discipline or Business preferred

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

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 Experience Level:
Mid-Senior Level

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Job Summary

Employment Type:
Full Time Employee
Job type:
Federal Contractor
Skill Based Partner:
No
Education Level:
Bachelor's degree
Work Days:
Mon, Tue, Wed, Thu, Fri
Job Reference Code
54535429
Salary
N/A
Licenses / Certifications:
N/A
Display Recommended WorkKeys®Recommended WorkKeys®:
N/A