Tech Transfer Manager (CPG-Pharma)

Prestige Brands Inc.

Prestige Brands is a company that focuses on product innovation and quality in the over-the-counter healthcare and household cleaning categories to better improve the lives of our customers and their world. For generations, our trusted brands have helped consumers care for themselves and their loved ones. We are the largest independent provider of over-the-counter products in North America and we are constantly improving and creating products that match the ever-changing lifestyles and needs of people and families everywhere.

Job Description:

The Technology Transfer Manager will be responsible for planning and directing work for technology transfer projects for commercially distributed OTC, Medical Device, Cosmetic, and Household products. The individual will lead cross-functional project teams, develop transfer plans and timelines, identify and resolve issues. The individual will communicate with and provide support to QA Managers, External Partners, Product Development personnel, Brand Managers and other functional experts as needed to ensure clear understanding and execution of transfer strategy, objectives and timelines.

Essential Duties and Responsibilities:

Lead cross-functional teams for implementation of production and cost improvement transfer projects.
Coordinate technology transfer activities and perform project management duties for each project
Develop clearly defined project goals and establish appropriate timelines
Coordinate project resources with assigned team members, agree on activities, assign project responsibilities, identify critical path issues
Work directly with external partners to facilitate issues resolution and track compliance during project implementation.
Affect outcomes by building professional relationships
Provide critical insight to the project teams on vendor technical, quality systems and engineering capability and expertise.
Develop and track the project budget with the team, including capital expenses.
Periodically present the status of the projects to the senior leadership team.
Actively participate in continuous improvement initiatives including product sourcing and Cost of Goods reduction projects in collaboration with the Operations business unit.

Qualifications:

Minimum of a Bachelor’s Degree in engineering/chemical engineering, a scientific discipline or equivalent.
Minimum 5 years of relevant work experience in pharmaceutical, medical device or related industry in a product manufacturing environment (OTC preferred)
Strong Quality Systems background in cGMP environment
Outstanding verbal and written communication skills are required, along with the ability to influence, and negotiate. Strong persuasion, presentation and negotiation skills are essential.
Demonstrated ability to manage projects, including ability to organize and manage multiple personnel and projects simultaneously.
Demonstrated experience with process specification and design; product scale up; pilot and small scale manufacture; phase in/phase out of production planning.
Proficiency in the use of Microsoft Office / Project products.

Travel: 10% ability to travel globally via car, plane, rail.

Manager, Tech Transfer, Global Patient Operations

Bristol Myers Squibb

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Role Description:

The Tech Transfer Manager will ensure consistent and robust processes are implemented at internal and external sites in support of global Patient Operations.

Travel up to 50% of time within the U.S. and Internationally may be required.

Come join Bristol-Myers Squibb for this unique opportunity to be part of the team building a leading edge Clinical and Commercial CAR T Platform that serves our patients with novel Bristol Myers-Squibb CAR T Therapies.

Responsibilities will include, but are not limited to the following:

Support process / technology transfer and change management for Cell Therapy at Bristol Myers Squibb’s manufacturing sites, contract manufacturing sites, and distribution/storage sites. This includes development of process documentation related to Patient Operations (ex. SOPs related to scheduling, apheresis receipt, packaging, e-system training, chain of identity).
Ensure alignment and harmonization of processes and communication that impact Patient Operations across multiple sites. Share operational and process learnings with the rest of the network.
Provide necessary analysis to support impact assessments and investigations related to Patient Operations processes.
Effectively communicate status and timing of tech transfer activities to key stakeholders
Identify risks to transfer timelines and mitigation strategies to ensure suitable response in place.
The role collaborates across many functional areas, including Quality, Supply Chain, Manufacturing, Science and Technology (MSAT) and others to ensure project advancement, rapid and best in class execution, and communication of challenges/opportunities.
Provide direct support to business units to meet Chain of Identity and Chain of Custody (COI/COC) policy requirements including FMEA risk assessments and process documentation.
Be a key contributor on the Business Process Excellence group to identify and drive process optimization projects and support department change management.
Regional analysis to source donor starting material in support of site activities
Ensure site activities are accurately represented in Patient Operations forecasts
Assist in management of operational reports

Skill and Knowledge Requirements:

Demonstrated ability to effectively work in cross functional teams (internally and externally), meet deadlines, and prioritize multiple projects working in a self-driven, performance/results oriented, fast paced environment
Knowledge and previous work experience with process mapping, Lean Six Sigma and business process reengineering.
Excellent verbal and written communication skills with ability to work with all levels within the organization
Demonstrated success handling initiatives of high complexity
Knowledge of performance measurement approaches, tools and metrics.
Excellent problem-solving skills
Understanding of large system implementations, especially focused on Supply Chain, Manufacturing, Quality, etc.
Able to manage time and elevate relevant issues to project lead and line management

Qualifications and Experience Requirements:

Undergraduate Degree with 5 years of experience in biotechnology operations and/or process transfer activities
Familiarity with cell therapy processes and cGMPs preferred.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

TECH TRANSFER SPECIALIST

Fresenius Kabi

The individual is responsible for independently or as part of a project team, planning, designing, tracking and implementing effective project technical support systems as well as facilitating multiple technical transfer activities (e.g., protocols, batch records, operating procedures, training materials, etc.) to achieve a successful transfer of products. The position will support multiple sites within North America and Europe and reports into the Director of Production and Technology Transfers.

The Technology Transfer Specialist will be working directly with Corporate Operations Management, Quality Assurance, Quality Control, Regulatory Compliance, Finance, Supply Chain, Manufacturing, Validations, Packaging Development and Engineering.

Responsibilities

This position will be primarily responsible for assisting Technology Transfer Leads and Technology Transfer Management with the execution of core transfer activities:

Development and coordination of related manufacturing transfer documentation

Standard Operating Procedure (SOP) and Specification creation and revisions

Execution of Investigative and stability studies

Performing Process & Engineering Studies

Creating and updating documentation needed for Regulatory Submissions

Method transfer and or verification studies

Creating new packaging documentation

Maintenance of the CPV program

Assists in the preparation and presentation of department KPI (Key Performance Indicators) through routine progress report updates to the management team.

Collaborates and communicates with other specialists and leaders to coordinate cross-project initiatives and activities.

Efficiently works with both internal and external resources to achieve technical business solutions within project guidelines.

Responds to operational issues and information requests within defined areas of responsibility while progressing on work assignments.

Continues to develop technical and administrative skills by way of training, seminars and certifications.

Requirements

Minimum of a Bachelors degree in physical science, engineering or equivalent experience.

One to three years experience with product development, manufacturing, quality control, or product transfer assignments that demonstrates tenacity to see projects through to completion according to established action plan; analytical skills necessary for problem solving issues as they arise.

Must possess good interpersonal skills to establish effective working relationships that are critical in a team environment.

Effective oral and written communication skill set. Requires proficient presentation and technical writing abilities.

Knowledge of pharmaceutical product development, manufacturing processes, validation, cGMP’s and FDA regulations for the Pharmaceutical Industry.

Senior Manager Tech Transfer / Process Development (Ireland based)

Amneal Pharmaceuticals

Qualified Pharmaceutical Scientist/Engineer with significant Process Development and Technology Transfer experience required to strategically direct site Scale-up and Technology Transfer of Metered dose and Dry powder inhalers in conjunction with Product Development group and Commercial Manufacturing. Understands Pharmaceutical Processing technologies, Equipment and Process/Technology Development.

Experience with Pharmaceutical manufacturing

Manage the site technical transfer operations.
Execute Scale-up and Technology Transfer of Metered dose and dry powder inhalers in conjunction with Product Development group and Commercial Manufacturing.
Understand DPI/MDI device design, associated ISO and CFR 820 regulations of combination device, functionality and manufacturing aspects.
Manage & execute the design and develop robust manufacturing processes in support of active inhaler technology including: authoring experimental protocols, writing work instructions, batch records, and technical reports.
Drive & promote cross functional project teams to support R&D operations and assist in the technical transfer of manufacturing activities from development to clinical/commercial manufacturing sites (both internal and external) including collaboration on manufacturing process development, batch records, material specifications, and oversight of manufacturing activities at external vendors.
Direct experience with operation of aerosol manufacturing equipment is highly desirable.
Demonstrated expertise in pressure filled MDIs and/or blister/capsule manufacturing process analytical technology and process improvement preferred. Understanding of Quality by Design concept and its application to pharmaceutical manufacturing is important.
Problem solving and creativity are critical skills in this role.
Demonstrated knowledge of cGMPs as they apply to controlled pharmaceutical environments as well as working knowledge of FDA and international regulatory guidelines for process and manufacturing development is necessary.
Excellent Communication skills, Project Management experience and strong execution background preferred
Experience with drug development necessary

Qualifications

MS in Industrial Technology, Chemical Engineering, or Pharmaceuticals Sciences preferred

Minimum 5+ years’ experience with pharmaceutical processing.

Travel: Yes, 20 % of the Time