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Senior Program Manager - BioServices

Company: Cryoport
Location: Morris Plains
Posted on: June 12, 2021

Job Description:

Senior Program Manager - BioServices - Morris Plains, NJ

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Job Title: Senior Program Manager - BioServices

Job Category: Staff

Department/Group: BioServices

FLSA Status: Exempt

Reports To: Director - Global BioServices

Travel Required: Yes, 10-20%

Position Summary

The BioServices Sr Program Manager plays a key role in developing and driving strategies, timelines, and resourcing with cross-functional partners to support client relationship development, project and program planning, implementation, and management. This will range from initial discussions with clients, development of the project requirements, documentation aspects of setting up the project and management of all project related activities through to study completion. Program Managers act in a consultative role to offer clients solutions to complex projects and services and will collaborate and coordinate internal teams to meet client expectations as well as company goals. This role is critical in anticipating and mitigating risks to ensure programs are flawlessly implemented and executed and succeed on all 3 constraints (scope, budget, and schedule).

Primary Responsibilities (include but are not limited to):

  • Serve as the central point of contact for clients and providing operational support including facilitating all program communications internally and externally and leading cross-functional teams in managing multiple project plans and client commitments.
  • Manages the delivery of all technical and service aspects of projects and studies for clients.
  • Provision of data and technical input to the Business Development Manager to help in the creation of proposals.
  • Collects all information on a study design including correct label texts, coordination of secondary packaging materials and tools, coordination of label production, production/review of all batch documentation for operations, coordination of shipments through the logistics department, and preparing and reviewing GMP documents in a timely manner.
  • Overall responsibility for ensuring that activities come together in a timely manner to meet the client and study requirements.
  • Ensure that risk mitigation plans are implemented to achieve project timelines.
  • Establish program schedules for continuous improvement projects, quality tracking, strategic initiatives, and Business Reviews by assigning key deliverables, metrics and communicating expectations and progress updates.
  • Initiates the involvement of appropriate departments, maintaining continuous communication with those departments, and ensures the work delivered to customers is of a consistently high standard.
  • Lead the execution of tasks as defined in the project plans to achieve the project goals, and actively identify and manage project risks.
  • Monitor and ensure compliance with time and delivery of all contractual commitments as stipulated in client agreements such as MSAs, SOWs and Quality Agreements.
  • Organization and delivery of training, including cross training of other members of Cryoport where appropriate.
  • Creates and/or supports the writing and review of departmental SOPs, Work Instructions & Technical Agreements.
  • Attends Project Meetings at the business or customer site. Leads and represents the business at kick off meetings as required by the customer.
  • Leads and facilitates customer teleconferences, visits and audits as required, and provides timely provision of customer reports and updates.
  • Interacts with Quality Assurance/Regulatory personnel to drive Problem Reports to closure.
  • Ensures customer needs are properly translated into quotation and has responsibility to monitor and amend the quote and budget as required.
  • Provides accurate and timely financial forecasting, revenue, and reporting.
  • Responsible for revenue recognition for projects and verifies final information for Accounting Department prior to invoices release.
  • Ensure all required import licences, pro-formas, and commercial invoices are prepared as and when required.
  • Ensure accurate order information is provided to accounting department and regular invoicing is completed.
  • Monitor and record change in the scope of contracts. Arrange for additional invoicing as required
  • Receipt of study related calls / issues. Log calls in system follow escalation procedure as appropriate. Monitor call logging system to ensure calls are closed out in a timely manner
  • Participates in cross-functional business process improvement activities as required.
  • Measure project performance using Project Management tools and techniques to monitor the project progress, identify and quantify variances and perform any required corrective actions.
  • Works closely together with the account manager to gain overall customer satisfaction.
  • Sets up and maintains study filing systems and maintains accurate records for all work undertaken.
  • Assists in setup of client project in Title21 (IMS) and manages material, ensuring Title21 is always current.
  • Applies Good Manufacturing Principles (GMP) in all areas of responsibility.
  • Good Manufacturing Practice - Investigates and reports on internal non-conformances. Assists others in investigations to issues not relevant to assigned studies.
  • Use of appropriate project planning tools to communicate milestones and critical path activities and responsibilities.
  • Works to optimize production schedules balancing the customer requirements with best use of available capacity.
  • Monitor and drive client specific, program-related gross margins and immediately report any deviation from projected targets.
  • Lead the regularly scheduled program communication to leadership team.
  • Facilitate team decision-making, identify and escalate issues, when appropriate.
  • Identify program expansion opportunities within existing client partnerships.

Competencies & Personal Attributes:

  • Understanding of logistical requirements for different countries - ideally.
  • Understanding of GMP / GXP requirements.
  • Requires excellent communication (verbal and written), organizational, and project co-ordination skills.
  • Flexible and adaptable with strong customer management and relationship building skills.
  • Able to analyze problems and define solutions.
  • Able to work under pressure and to support others within a team.
  • Ability to build customer commitment
  • Capability to support operational excellence (30/30)
  • Natural ability to focus on priorities (80/20)
  • Instinctive team player, used to collaboration, and accountability (90/10), Ability to work collaboratively and motivate others to action.
  • Emphasis on business growth
  • Expert job knowledge in Project management with strong supply chain/operations sense
  • Creative & innovative thinker
  • Excellent interpersonal skills (at all levels)
  • Reliability & dependability, Ability to meet deadlines consistently and manage multiple projects simultaneously
  • Focused on continuous personal and professional development
  • Effective at problem solving and decision making
  • Excellent safety awareness
  • Results driven, high attention to detail and process-oriented
  • Excellent problem-solving & team building skills and comfortable managing ambiguity
  • Strong business acumen, communication, and presentations skills
  • Ability to work independently and as an active member and leader of a team is essential
  • Ability to address delicate situations and effectively manage conflict to maximize project team progress

Qualifications and Education Requirements:

  • Bachelor's degree in a life sciences field. Master's degree preferred.
  • 3-4 years of hands-on experience managing projects related to the support of clinical trials or commercial programs. Managing programs as an Associate Project Manager / Project Manager in advanced (cell and gene) therapies preferred.
  • 4 years experience in a client-facing role in the pharma, biotech or medical device industries.
  • Relevant experience of clinical trial import, packaging, storage, and logistics preferably to include handling complex protocols, key clients, and business objectives.
  • Must be proficient in Microsoft Project, Word, Excel, and PowerPoint

Preferred Experience:

  • Proficiency in appropriate project planning tools e.g., Celoxis / MS Project to communicate milestones and critical path activities and responsibilities.
  • Project Management qualification desirable (e.g., CAPM, PRINCE2, PMP).
  • Good working knowledge and experience using Lean and 6-Sigma tools (or equivalent).

Keywords: Cryoport, Newark , Senior Program Manager - BioServices, Other , Morris Plains, New Jersey

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