Technical Operations Manager (CF-33970078)

Location: San Diego, California, United States    |  Remote Working Available
Salary: competitive
Sectors: Healthcare
Job Type: Contract
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Title: Technical Operations Manager

San, Diego, CA

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

These may include, but are not limited to:

  • Collaborate with cross-functional CMC Subject Matter Experts (SMEs) to develop robust project plans and lead key deliverables for long-term, complex CMC programs
  • Facilitate decision-making, collaboration and problem-solving with people at all levels of the organization to accomplish shared program goals
  • Provide critical direction to cross-functional CMC teams for planning, organizing, developing, and integrating multiple work streams
  • Lead day-to-day communication for daily tasks and priorities for functional CMC team meetings and drive closure of open actions. Coordinate and facilitate team agendas, meetings, and presentations; generate meeting minutes
  • Closely supervise, support, and provide necessary direction to project teams to coordinate adherence to timelines and deliverables; evaluate outcomes and results and provide recommendations for next steps
  • Create and maintain efficiency tools that support improved coordination, control, and oversight of routine activities
  • Analyze existing processes to identify and implement efficiency-enhancing solutions to optimize process flows and resolve rate limiting factors, key dependencies, and resource needs
  • Develop tracking dashboards and alerts to identify any risks that can delay or impact program; work with project lead to develop mitigation plans
  • Act as cross-functional liaison to resolve project team issues and facilitate decision-making within the team
  • Support the coordination of activities with CDMOs, as necessary

ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:

  • Management of multiple projects and timelines concurrently
  • Training team members on efficiency tools and practices
  • Developing work instructions or SOPS that support process efficiencies
  • Communicate timely status reports to key personnel, both internal and external
  • Facilitate inter- and intra-team communications during the execution process
  • Other duties as assigned

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

  • A minimum of a Bachelor's degree in a life science and 7 years proven experience in CMC process development, a manufacturing, and/or analytical development (an equivalent combination of experience and education may be considered)
  • Validated experience in following areas: regulatory filings, drug development, product commercialization, and project management in the pharmaceutical or biopharmaceutical industry
  • Technical knowledge of biological process development, manufacturing practices, product lifecycle management, regulatory filings, and/or analytical development
  • Proven track record to lead multiple projects, identify and resolve CMC issues
  • Excellent interpersonal skills (verbal, written, and presentation skills) for effectively working with all levels of management and departments within the company
  • Demonstrated experience in the development and delivery of effective project updates, summary presentations, and timelines to cross-functional teams
  • Ability to understand, translate, and implement a program strategy in a constantly evolving and multifaceted environment
  • Demonstrated successful experience influencing teams
  • Strong organizational skills to maintain a high level of productivity, innovation, and a sense of urgency to ensure assignments are completed on-time and on-budget with a high level of quality
  • Solid knowledge of MS Project and SharePoint
  • Experience working with contract development and manufacturing organizations (CDMOs) a plus
  • PMP certification is preferred

TECHNICAL KNOWLEDGE REQUIRED:

Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required:

Software Knowledge: Windows, MS Office (Outlook, Word, Excel, Powerpoint, Project).

INTERNAL AND EXTERNAL RELATIONSHIPS:

  • Routinely collaborate with CMC management to align on goals, priorities, budgets, and schedules
  • Productively get along with CMC team members to ensure timely completion of deliverables and team objectives against ambitious timelines
  • Collaborate with and mentor CMC team members on creating and carrying out plans and processes to solve difficult problems
  • Work with scientists on development teams to prioritize studies and ensure required scientific results are available to meet ambitious timelines
  • Build and maintain relationships with key personnel

EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting to 40 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

TRAVEL:

Travel may be required up to 10% of your time


EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Computer Futures please visit www.computerfutures.com

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