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Manufacturing Supervisor

Employer
Aspen Neuroscience
Location
San Diego, California
Start date
Mar 25, 2023

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Discipline
Manufacturing & Production, Manufacturing/Mechanical
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach
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DESCRIPTION:


Aspen Neuroscience is looking for a Manufacturing Supervisor with a passion for learning to join our cell therapy manufacturing team. Reporting to the Senior Manager, Manufacturing Operations, this working supervisor is a key role in the production of cells and intermediate products related to induced pluripotent stem cells (iPSC). The ideal candidate is a collaborative team player with tissue culture experience who is driven to help patients and has a desire to mentor others. As a leader in the department, this person will support management in key meetings and will handle confidential material including personnel, clinical, and company proprietary information. 


DUTIES AND RESPONSIBILITIES:

  • Directly supervise Manufacturing team (Tuesday-Saturday shift). Lead production floor activities and assignment of roles in the manufacturing area to ensure timely completion of tasks in a GMP plant.
  • Manage and oversee the planning, implementation, and maintenance of events and equipment used in the Manufacturing area.
  • Supervise the floor operations to maintain safety, compliance, and aseptic operations. Ensure periodic Safety and Housekeeping audits are conducted. 
  • Ensure the effective use of materials, equipment, and personnel during production by being proactive with troubleshooting manufacturing product challenges.
  • Make process related decisions quickly, while informing upper management and quality department, to immediately address urgent manufacturing issues.
  • Monitor and control labor (absenteeism, vacation, overtime, etc.) and other group expenses.
  • Monitor and control inventory of material and supply items used both for APS, OPR Qualifications, Engineering runs, general production, and training needs.
  • Collaborates with Sr Manager of Manufacturing to manage personnel, which can include, writing and overseeing of personnel goals and evaluations, scheduling, management of personnel issues, training, and recruitment of Manufacturing positions.
  • Work efficiently with cross-functional groups in Process Development, Quality, and Research & Development departments to ensure production targets are met; and that product and process comply with cGMPs, product licenses, and corporate policies.
  • Provide technical expertise to resolve manufacturing issues.
  • Ensure that operations and documentation conform to cGMP standards and that all SOPs and Batch Records are maintained to reflect current manufacturing methods. Write and revise documents to support Manufacturing activities. 
  • Develop team capabilities and enable continued staff development. Uphold and maintain clear and consistent performance management practices and expectations.
  • Represent department in support of plant cross functional teams’ meetings when needed. Lead efforts to communicate and address daily and atypical events reporting.
  • Create, maintain, and report trending data for MFG production activities.


    • EDUCATION AND EXPERIENCE:

    • Bachelor’s degree in a life science or other technical area (chemistry, pharmaceutical sciences, chemical engineering) or an equivalent level of education and/or experience.
    • Minimum 7 years of prior work experience, including 1-2 years in a lead or supervisory capacity, in a GMP Manufacturing facility (Biotechnology or Pharmaceutical industry).
    • Extensive Experience with cell culture operations and familiarity with execution of moderate to complex scheduling activities is a must.


    JOB SPECIFICATIONS:

    • Firsthand understanding of mammalian cell culture, composing and supplementing media, cleanroom (ISO 7 and 5), fibroblasts, primary tissue culture, working in a GMP facility, and iPSC cells preferred.
    • Knowledge of ISO, Quality Systems, and FDA regulations.
    • Ability to address conflict resolution and inspire and motivate a manufacturing team through leadership and implementation of effective management tools.
    • Understanding of the importance of confidentiality.
    • Ability to be a supervisor that can work alongside their team.
    • Self-motivated and driven to independently establish and accomplish departmental goals and objectives.
    • Advanced technical writing, organizational, and presentation skills.
    • Excellent oral and written communication, interpersonal, analytical, and computer skills.
    • Solid knowledge of Microsoft Office programs and other project management tools.
  • Ability to handle multiple projects with changing deadlines and prioritize accordingly.
  • Must be able to stringently follow established company rules, regulations, and safety precautions to maintain quality standards.
  • Ability to work in fast paced, dynamic office area, cleanroom, and open lab space requiring differing gowning requirements.
  • Ability to work a flexible schedule. Overtime, holiday, and weekend work may be needed to meet the needs of the current manufacturing project. 
  • Ability to understand the needs of key collaborators and internal customers; and interact effectively to achieve alignment.
  • Must be responsible and accountable for delivering functional area objectives on time and within budget.


    • EEO and Employment Eligibility:

    Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees.

    Total Rewards and Culture:

    Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, onsite gym, and other wellness perks.

    The anticipated salary range for candidates who will work in San Diego is $90K to $135K annually.  The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc.  Aspen Neuroscience is multi-state employer, and this salary range may not reflect positions that work in other states.

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