Nature and Scope of JobPortfolio/Program manager for multiple concurrent Manufacturing Execution System (MES) projects at MA Bio Ops, tracking all relevant milestones and related Change Controls and CAPAs.
Primary Responsibilities- 3+ years' experience with MES systems (PAS-X preferred) as well as relevant interfaces (ERP, Automation, Lab Systems).
- Direct experience with Biologics manufacturing processes and equipment.
- Understand the ISA-95 and ISA-88 models.
- 5+ years' experience in digital project and program management in a GMP environment.
- Experienced with common project management methodologies including Agile and Waterfall.
- Expected to be able to work independently, take initiative, and navigate complex matrixed environment to influence individuals and teams across the organization.
- Comfortable working with external vendors, where applicable.
- Able to lead meetings, identify projects risks, and understand cross project dependencies.
Additional Responsibilities - Performs other related duties and assignments as required
Qualifications- Experience with PAS-X MES system.
- Experience with Track Wise, Veeva systems (or similar)
- Experience with Atlassian's Confluence and JIRA software.
- Knowledge of Automation Systems in GMP manufacturing operations.
Education & Certifications - Bachelor's degree in Computer Science or Information Systems or related field.
- Master's Degree preferred
Working ConditionsThe working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
- Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
- Operate other office productivity machinery, such as a calculator, scanner, or printer.
- Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
DisclaimerThis job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
CompensationSalary/Hourly Rate Range (W2): USD 110.00 - 120.00
The base salary/hourly rate range represents the anticipated low and high end of the USDM's compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate's qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.
Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.
Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.
All employees are eligible for USDM's rewards and recognition program.
For more details about our benefits, visit us here: https://usdm.com/careers
