Senior Specialist Manufacturing Programs

Job Summary

The Manufacturing GMP Specialist, Manufacturing Programs is responsible for leading and managing Aseptic and GDP Programs within the Production Department at Bora Pharmaceuticals Baltimore site. This role will focus on ensuring programs are established and maintained that will lead to minimal deviations, promote a culture of quality and compliance, while driving a sense of continuous improvement and operational excellence. This role will provide subject matter expertise with the ability to train those who are less experienced on GDP, GMP, and aseptic techniques. The Sr Specialist, Manufacturing Programs will provide direction on the manufacturing floor to other operations staff members, assist with problem solving/troubleshooting, and escalate risk when necessary.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Identifies, plans, and implements Aseptic and GDP programs and solutions to enable the manufacture of biopharmaceuticals in a high quality, faster and more cost-effective manner.
• Reviews and approves executed Batch Release (BR).
• Review and approve Change Controls to BR or manufacturing process changes
• Review and approve MFG deviations.
• Serve as a subject matter expert in Aseptic Processes and Good Documentation Practices within the Production Department.
• Interfaces with Production, Batch Record Review Team, and supporting teams.
• Writes, revises and executes all types of controlled documentation (SOP’s, Production Batch Records, Technical Reports, Protocols, etc.).
• Identifies trends and implements corrective actions in GDP and Aseptic programs; updates to Emergent management and inter-departmental teams.
• Applies lean manufacturing tools and methodologies for the progression of process improvements (Kaizen, A3, Value Graph, Kata, etc.).
• Develops project plans including work scope, timeline and cost estimates for process improvements.
• Participate as department representative in various site/company initiatives.
• Participate in site regulatory inspections or client audits as needed.
• Complete regulatory and client audit observations.
• Demonstrates, understands and adheres to Bora Pharmaceuticals policies, GMP standards and safety procedures.
• Leads/facilitates root cause investigations and/or problem-solving initiatives.
• Establishes tracking and trending analyses of cGMP production runs.
• Back up to Production Supervisors when required.
  
  

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

Iii. Minimum Education, Experience, Skills

• Minimum of 8 years of biopharma experience
• Bachelor’s degree preferred
• Strong knowledge in Aseptic Manufacturing in GMP environment
• Knowledgeable in application and practices of current GMP’s, international regulatory requirements and guidelines.
• Computer literate (Word, Excel and PowerPoint)
  
  

Compensation Range

$75,789.00 - $113,684.00

Bora Pharmaceuticals Injectables, Inc. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals Injectables, Inc. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category