Headquartered in Stockholm, Sweden, Swedish Orphan Biovitrum AB is an international biopharmaceutical company dedicated to transforming the lives of individuals
Technical Operations Program Manager – Associate Director
Location
California
Posted
103 days ago
Salary
$153K - $211K / year
Seniority
Senior
Job Description
Technical Operations Program Manager – Associate Director
Sobi - Swedish Orphan Biovitrum AB
• 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 Guides
Related Categories
Related Job Pages
More Program Manager Jobs
Senior Program Control Manager
ASRC FederalASRC Federal, a wholly owned subsidiary of Alaska’s largest Alaskan-owned and operated company, the Arctic Slope Regional Corporation (ASRC), is a leading provider of mission-cri
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description 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 - Report on and manage Division results with direct interaction with the Division Vice President/General Manager - Develop program related financial data and metrics and lead program budgeting and forecasting - Provide oversight on financial tracking and the efficiency and effectiveness of financial programs - Apply understanding of the strategic picture and analyze financial data monthly - Coordinate and participate in month end closing - Manage a remote team in multiple locations - Serve as a business partner and adviser to leadership on all program financial matters Qualifications - Bachelor's Degree in related discipline - Minimum of 8+ years Program Control/Program Financial experience in a federal government contracting environment - At least 5 years of managerial experience Requirements - Advanced Excel skill set, proficiency with MS Office - Advanced working knowledge of Costpoint, TM1 and Cognos - Strong accounting background to include month-end closing - Experience in Program Finance & Analysis - Working knowledge of rates and service centers - Proven experience in analyzing financial data as well as financial reporting and forecasting - Experience with pricing contracts and new business bids - Experience with developing financial models including EACs and ad-hoc analysis - Proven partnering with multiple organizations to support Program Management and cross-functional teams - Ability to travel as needed for business needs - US citizenship and ability to meet federal government background checks Benefits - Competitive pay and benefits packages - Health care, dental, vision, life insurance - 401(k) - Education assistance - Paid time off including PTO, holidays, and any other paid leave required by law EEO Statement ASRC Federal and its Subsidiaries are Equal Opportunity employers. All qualified applicants will receive consideration for employment without regard to race, gender, color, age, sexual orientation, gender identification, national origin, religion, marital status, ancestry, citizenship, disability, protected veteran status, or any other factor prohibited by applicable law.
Program Manager Support Services
Koniag Government Services, LLCKoniag 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.
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description 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 programs. - Management of cross-functional projects and initiatives. - Proactive and solutions-oriented management of program operations and integration issues. - Applying project management skills to ensure transparency, reporting, and successful projects. - Maintain relationships both within KGS and with client leadership. - Utilize project management expertise to manage workflows, processes, risks, communications, resources, and quality. - Determine program needs and direct project management as needed. - Identify risks, concerns, or issues and escalate to management as appropriate. - Exercise judgment to make decisions and ensure programs/projects are effectively progressing. - Lead regular cross-functional informational or working meetings, including effective agenda planning, facilitation, and tracking/follow up on deliverables until closed. - Collaboration with Acquisition & Business to ensure Tenant Panel Management Scope is in alignment with Acquisition and contracting PMO and government department. Qualifications - PMP Certification - 6-10 years of PM experience - Bachelor’s Degree Benefits - Competitive compensation - Extraordinary benefits package including health, dental, and vision insurance - 401K with company matching - Flexible spending accounts - Paid holidays - Three weeks paid time off - And more Company Description 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. - Wholly owned subsidiary of Koniag - Applies proven commercial solutions to a deep knowledge of Defense and Civilian missions - Provides forward-leaning technical, professional, and operational solutions - Enables successful mission outcomes for customers through solution-oriented business partnerships - Committed to exceptional service delivery - Ensures long-term success with a continuous improvement approach
• Manage the multi-year execution roadmap, progress tracking and sustainment of GEHC’s Enterprise Change Management effort. • Support change practitioners of each project in onboarding, structuring, and coaching project teams to ensure clarity, progress, and alignment. • Ensure initiative change plans are realistic, resourced appropriately, and executed with discipline and consistency using Prosci ADKAR methodology. • Track and manage interdependencies across initiatives, identifying risks and resolving impediments quickly. • Report progress, escalate decisions when necessary, and maintain transparency with senior leadership. • Conduct change readiness assessments and pulse checks on ECM project to understand adoption, sentiment, and barriers to execution. • Partner with cross-functional colleagues to ensure change initiatives create measurable change value, with clear baselines and tracking mechanisms. • Coordinate across all key change workstreams to ensure enterprise-level alignment and consistency on application of our one consistent change model and methodology.
Program Director – Aviation
WoolpertFounded in 1911, Woolpert is the premier architecture, engineering, and geospatial (AEG) firm.
• Collaborate closely with the Aviation Market Director and dedicated aviation staff nationally to deliver goals. • Lead the business growth of key aviation planning and design (horizontal and vertical) services by developing a pipeline of new and existing business/contract opportunities throughout the US. • Drive partnerships with other consultants in the aviation industry to win and perform projects. • Guide growth of the practice based on emerging trends, technologies, policies, and available funding sources that build on our existing reputation and relationships. • Maintain a thought-leader/Subject Matter Expert profile in the industry by providing industry leading customer service to existing and potential clients. • Guide the appropriate level of collaboration between Project Managers and the cross-functional technical (discipline) teams. • Manage, monitor, and forecast metrics including Backlog, Profit and Loss, Sales, Net Revenue, Utilization, Continuing Education, and Non-Billable Travel and Expenses for the Practice. • Lead and support where appropriate all shortlist presentations for prospective clients and participate in contract negotiations with clients. • Provide quality reviews of project documentation including work plans thru final deliverables.

