Manager, Drug Substance Operations

Job Description

Our Manufacturing Operations teams are the people that make therapies for our patients. We work in the manufacturing plants with a Safety First Quality Always mindset striving for continuous improvement and earning our right to produce. We work in local plants connected to our global manufacturing network supplying the highest quality of raw materials intermediates and finished products.

This role is within a capital project start-up in Durham North Carolina. The new facility will include end-to-end processing of drug substances drug products including biotech culture growth harvest lyophilization product inspection utilities and warehouse.

The ideal candidate for this role will be an energetic leader with strong interpersonal leadership collaboration skills and has demonstrated the ability to meet immediate business objectives even through adversity. This role will support drug substance manufacturing in regulated clean room environments complying with current Good Manufacturing Practices in the form of project management and ultimately shop floor leadership.

Key Responsibilities for a Drug Substance Manager

Accountability Project Support

• First-line operations supervisor with a team of individual contributor production direct reports

• Supports project team as operations leader through start-up qualification through licensure and ramp-up of the facility

• Leads and provides input into continuous improvement opportunities

Accountability Operational Leadership

• Ensure that Shift(s) objectives are achieved while reliably supplying a quality product at a competitive cost consistent with our Company Regulatory Agency and State and Local code requirements for quality good manufacturing practices (GMP) equal employment opportunity finances labor employee environment and safety not in that order

• Tactical and strategic Shift(s) management including collaboration with indirect staff

• Promote the behaviors and principles that drive continuous improvement

Additional

• Typically coordinates and supervises the daily activities of individual contributors

• Sets priorities for the team to ensure task completion; coordinates work activities with other supervisors

• Decisions are guided by policies procedures and business plan Receives guidance and oversight from Operations Associate Director and Director

• Interprets client and/or customer needs and assesses requirements

• Applies supervisory skills to improve efficiency and accomplish operational objectives within own unit

• Identifies and resolves standard day-to-day technical and operational problems within own unit

• Sets priorities for unit to meet daily deadlines; develops plans to meet short-term objectives

• Works within budgetary/ financial objectives set by Director

• Makes decisions guided by policies and standard operating procedures that impact the efficiency and effectiveness of own unit

• Compliance - Creating and sustaining a culture that ensures that compliance (Safety Environment cGMP etc.) are imperatives for the business Establishing a Right First Time culture by reducing waste and constantly driving continuous improvement Review and approve compliance documents as per procedures or need

• Supply/Support Tier - Exercise judgment and decision making to ensure a quality product is reliably produced while managing cost Shift(s) supply performance metrics (Schedule Adherence Release on Time Customer service performance Product Lead Time etc.)

• Continuous Improvement - Accountable for developing a Company Production System (CPS) and continuous improvement culture while achieving CPS Targets and business results for the Shift(s) Develop strategic initiatives related to the manufacturing process equipment and human resources in support of long-range operating plans Report Shift(s) monthly metrics and any action plans to address gaps to the Associate Director and/or Director Identify prioritize and champion improvement initiatives to improve process efficiency cycle time and yield reduce process variability and eliminate waste

• Financial Stewardship Accountable for meeting the Shift(s) operating budget and continuously reducing cost Ensure members of the Shift(s) have business acumen and understand how they may impact business finances

• People Management Creating and sustaining a highly engaged workforce through the utilization of Company Leadership Behaviors and Inclusion Provide coaching on professional development and career paths Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation Provide feedback and input on performance evaluations for indirect staff Support Talent Management

• Direct coordinate provide guidance and counseling to group leaders to assure optimum quality and quantity of finished products

• Keep all team members informed on current policies and procedures and all other plant communications

• Enforce all prescribed safety rules and regulations and take prompt corrective action concerning potential safety hazards

• Provide leadership in establishing and maintaining a high efficiency and productivity level from the team members while maintaining a focus on Safety First and Quality Always

• Identify root causes of manufacturing issues and implement corrective action to minimize downtime with a focus on Safety Quality Delivery and Cost in that order

• Actively develop members to obtain maximum potential

• Support and lead/participate in the Hoshin process and advocate for and continually strive to achieve our Vision

Education

• High School Diploma AND at least Six (6) years in a manufacturing technical support or Military role. OR

• Bachelors degree in a technical field AND at least four (4) years in a manufacturing technical support or Military role.

• Bachelors degree and two (2) years of experience in a direct GMP biotechnology and manufacturing setting.

Required Experience and Skills

• Ability to develop and lead others

• Ability to be flexible and understand the risk

• Continuous improvement

• Conflict resolution

• Leadership style adaptive; high-performance coaching; a servant leader

• Successfully maintain Aseptic Gowning qualifications (Aseptic gowning includes all skin and hair covered).

• Candidate must pass a TB Blood and Chest X-Ray prior to start date.

Preferred Experience and Skills

• Minimum two years in relevant manufacturing or processing (aseptic/sterile bulk solid oral dosage packaging etc.)

• Demonstrated knowledge of Lean/Six Sigma

• Demonstrated experience of interacting with the site divisional or regulatory audits

Schedule Requirements

• The position is for 2nd Shift - 2pm - 10:30pm - Overtime required upon request

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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