Employment Opportunities
Duties and Responsibilities:
Position reports to the Vice President of Technical Operations.
Manage the technical requirements and operations for manufacturing a parenteral pharmaceutical diagnostic agent according to cGMPs.
- Equipment operation and maintenance
- Production activities (cleaning, sterilization, component prep, formulations, fill/finish)
- Scheduling and resource allocation
- Budgeting and contracts
- Documentation
Oversee and coordinate internal manufacturing resources to:
- Meet aggressive timelines
- Solve production and technical problems
- Assess bottlenecks
- Improve yield and efficiency
- Reduce cost of goods
- Ensure compliance with cGMP’s and Quality Standards
- Complete the development and execution of all applicable manufacturing and process-related documentation (validation protocols, batch records, SOP’s, etc.)
Play an integral role in manufacturing-related capital projects and equipment installations to support manufacturing activities.
Work closely with Process Development to evaluate manufacturing technologies, develop equipment specifications, and transfer/integrate new process.
Work closely with Facilities Services to evaluate expansion opportunities and requirements, develop facility specifications, and complete equipment installations and build-outs.
Requirements:
- BS Degree or higher in Science or Engineering
- 10 – 15 years of manufacturing experience in the pharmaceutical industry
- Solid understanding of parenteral manufacturing, aseptic processing, lyophilization, facility design/build, clean-in-place (CIP)/sterilize-in-place (SIP) technologies, manufacturing process technical transfers, cGMPs and validation are essential.
- Familiarity with or experience in microparticle technology and spray drying are beneficial.
- Organizational, communication and excellent personal work management and writing skills, as well as a demonstrated ability to solve a wide range of technical problems, are expected.
- The ability to manage, motivate and inspire cross-functional teams and the manufacturing staff is essential.
- The ability to successfully handle multiple projects, aggressive timelines and the demands is a must.
Senior Director/Director of Quality Systems
Duties and Responsibilities:
- Coordinate the implementation of a compliant Quality System to provide assurance that products manufactured are in compliance with the US and EMEA cGMPs, regulatory requirements and applicable corporate policies
- Compliance oversight of all Quality Control Chemistry Department activities to assure that the laboratory is compliant with US and EMEA cGMPs, regulatory requirements and applicable corporate policies
- Review of standard operating procedures, specifications, test protocols, final reports for compliance with cGMP requirements
- Development and Implementation of standard operating procedures and policies to assure compliance with cGMP requirements
- Performance of compliance audits, development of proposed corrective action plans based on interpretation of cGMPs, cGLPs, and cGCPs preparation of final audit reports, and reports on compliance status
- Plan and schedule subordinate goals, objectives, and activities
- Participation and co-chair of Material Review Board and Specification Review Board Meetings
- Interface with Department Directors and Managers regarding additions, changes and improvements to the overall Quality System
- Update Senior Management on Compliance goals and achievements
Requirements:
- Minimum Bachelors Degree with a minimum of 10 years Quality Assurance/Quality Control experience in the pharmaceutical industry
- Direct experience in interacting with regulatory agencies and familiarity with US and EMEA cGMP regulations and guidance knowledge of cGLP, cGCP regulations very desirable
- Strong background and demonstrated effectiveness in Quality Assurance and compliance of FDA regulated pharmaceutical products and Quality Control Laboratory Management
- Possesses a thorough understanding of the scientific and technical aspects related to QA/QC of drug product manufacture, method and process validation
- Demonstrated leadership skills, outstanding interpersonal communication and motivation skills. Effective project management skills and problem solving ability are essential
- Excellent writing, editing, time management, communication, technical writing, presentation development, facilitation, and organizational skills required
- Excellent understanding of Microsoft Office and Microsoft Project software, knowledgeable in the use of electronic document management systems
- Strong organizational skills, detail oriented, with the ability to work in multi-task working environment with minimal supervision
Associate Director, Compensation and Benefits
In this role you will be responsible for all aspects of Compensation and Benefit programs including:
Compensation
- Manage compensation plan analysis and design, including salary systems, incentive bonus plans, sales compensation, performance management/annual review process and stock option plans. Analyze compensation survey data and apply job evaluation techniques to establish competitive and equitable compensation rates.
- Prepare compensation and equity plan analysis and related documents for quarterly Compensation Committee meetings and annual review process.
- Manage and oversee local, state and federal laws regulating compensation practices.
- Provide guidance and make recommendations to all levels of management on compensation issues, policies and procedures such as job families, grades, new hires, transfers, adjustments and promotions.
- Participate in annual industry specific salary surveys (Radford, TSG, SIRS).
- Manage stock option plan administration, approvals and documentation.
- Network with HR staff at local companies.
Benefits
- Manage and oversee benefits programs, documents, Summary Plan Descriptions, billing, claims issues and administration. Manage one direct report: Benefits Specialist.
- Prepare and conduct communications and meetings during the open enrollment process for medical, dental, flexible spending, 401(k), and ESPP.
- Work with insurance brokers during annual renewals to review and benchmark current benefits plans to ensure competitiveness in the marketplace.
- Make recommendations for new programs and improvements to ensure benefits are competitive for recruitment and retention purposes.
- Participate in benefits surveys.
- Manage 401(k) plan including relationship with vendor, compliance/non-discrimination testing, 5500 and plan documents. Coordinate quarterly 401(k) committee meetings, annual fund review and financial planning assistance with outside vendor.
SOX Compliance
- SOX Compliance - manage quarterly audit of HR related procedures.
- Ensure no unmitigated significant deficiencies or material weaknesses.
- Partner and work closely with members of the finance department on Payroll and stock option administration. Ensure Payroll changes and stock option grants are approved and administered based on SOX regulations.
- Ensure compliance with respect to all SOX related components of the hiring/recruiting process. (job req process, budget variance approval and related documentation).
HRIS/p>
- Project Manager for the selection and implementation of an HRIS system.
- Analyze reporting needs and design system specifications.
- Manage system implementation process.
Additional Responsibilities:/p>
- Work with other HR staff on various projects and programs as needed (i.e. update employee handbook and policies as needed).
Qualifications:/p>
- Bachelor’s degree required.
- 10-15 years experience in compensation and benefits in a public biotechnology or pharmaceutical company is required.
- Must have strong quantitative, and analytical skills.
- Advanced knowledge of compensation theory and practices.
- Excellent organizational skills and strong attention to detail.
Acusphere Inc. is seeking a Director of Validation to develop and evaluate quality processes and systems standards to ensure compliance with company standards and governmental regulatory requirements. Key responsibilities will include; managing, developing and implementing validation strategies, master plans, protocols and test procedures to ensure production, utilities, computer systems and products meet with appropriate regulatory agency validation requirements, internal company standards and industry current practices. In addition you will oversee and review area processes and procedures and make recommendations for changes and improvements.
The ideal candidate will have a BS/MS in Engineering and 10-15 years aseptic biopharmaceutical process and utility validation experience in a lead role.
This page was last updated March 18, 2008.