Senior Program Manager - BioServices
Location: Morris Plains
Posted on: June 12, 2021
Senior Program Manager - BioServices - Morris Plains, NJ
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Job Title: Senior Program Manager - BioServices
Job Category: Staff
FLSA Status: Exempt
Reports To: Director - Global BioServices
Travel Required: Yes, 10-20%
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
- 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
- Ensure that risk mitigation plans are implemented to achieve
- 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
- Lead the execution of tasks as defined in the project plans to
achieve the project goals, and actively identify and manage project
- 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
- Provides accurate and timely financial forecasting, revenue,
- Responsible for revenue recognition for projects and verifies
final information for Accounting Department prior to invoices
- 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
- 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
- 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
- Lead the regularly scheduled program communication to
- Facilitate team decision-making, identify and escalate issues,
- Identify program expansion opportunities within existing client
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
- 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
- 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
- Effective at problem solving and decision making
- Excellent safety awareness
- Results driven, high attention to detail and
- Excellent problem-solving & team building skills and
comfortable managing ambiguity
- Strong business acumen, communication, and presentations
- 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
- 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
- Proficiency in appropriate project planning tools e.g., Celoxis
/ MS Project to communicate milestones and critical path activities
- Project Management qualification desirable (e.g., CAPM,
- 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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