Technical Operations Program Manager – Associate Director

Program ManagerProgram ManagerFull TimeRemoteTeam 1,001-5,000Since 1991H1B No SponsorCompany SiteLinkedIn

Location

California

Posted

13 days ago

Salary

$153K - $211K / year

Bachelor Degree10 yrs expEnglish

Job Description

• Lead an international cross-functional technical CMC team, associated functions like Quality and impacted CMO/CLOs to deliver all required technical documentation supporting an approvable NDA Module 3 • Project manage all key CMC deliverables, incl underlaying reports • Coordinate team interactions ensuring team meetings have structure and purpose • Assure integrated program plans are in place including cross-functional interdependencies • Coordinates the identification and mitigation of program issues and risks • Coordinating the review process of technical documents (ie, protocols, reports, master and executed batch records, change controls, deviations, etc.) • Responsible for program budget and long-term projections – budget planning and tracking

Job Requirements

  • > 10 years of pharmaceutical industry experience
  • Significant hands-on experience in CMC Development and Program/ Project Management roles in complex environments
  • Experience in working with cross-functional teams in the pharmaceutical industry, preferably in a global setting
  • Excellent Project management skills: Decision- and action-oriented to facilitate quick decisions in alignment with all stakeholders
  • Experience in managing detailed program timelines to ensure timely delivery of key milestones
  • Identify and evaluate risks associated with project activities and take appropriate actions to control or mitigate risks
  • Scientific and technical background of CMC development and manufacturing in drug substance small molecule, no-sterile products
  • Demonstrable experience of working in cross functional team with ability to multitask, prioritize and be an effective decision maker
  • High level of flexibility and effectiveness in cross-functional, international, and cross-regional environments
  • Proven ability to adapt to an ever-changing business environment
  • Fluent in English, intermediate to full proficiency in Chinese is a plus.

Benefits

  • Competitive compensation for your work
  • Generous time off policy
  • Opportunity to broaden your horizons by attending popular conferences
  • Emphasis on work/life balance
  • Collaborative and team-oriented environment
  • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Related Categories

Related Job Pages

More Program Manager Jobs

Full TimeRemoteTeam 201-500

ASRC Federal is seeking a Senior Program Control Manager to provide strategic leadership for division-level business operations, finance, and program control within the Defense and Intelligence Operating Group. Support and lead the Program Management Office at a division level Re...

United States

Program Manager Support Services

Koniag Government Services, LLC

Koniag Government Services (KGS) is an Alaska Native Owned corporation supporting the values and traditions of our native communities through an agile employee and corporate culture that delivers Enterprise Solutions, Professional Services and Operational Management to Federal Government Agencies.

Program Manager13 days ago
Full TimeRemoteTeam 1,001-5,000

This position is remote and involves supporting Kadiak and our government customer as a Program Manager Support Services. Overall project ownership and management of key projects, focusing on both short-term initiatives and long-term strategic direction and objectives for the pro...

United States
Full TimeRemoteTeam 10,001+Since 1892H1B Sponsor

Program Manager in Enterprise Change Management at GE HealthCare driving change initiatives.

United States
$142.4K - $213.6K / year

Program Director – Aviation

Woolpert

Founded in 1911, Woolpert is the premier architecture, engineering, and geospatial (AEG) firm.

Program Manager13 days ago
Full TimeRemoteTeam 1,001-5,000Since 1911H1B Sponsor

Program Director leading aviation planning and design initiatives at Woolpert

United States
$165K - $206.2K / year