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CMC Project Manager_technology transfer_Bio-Pharmaceutical industry

Company: Infotree Service Inc
Location: Cambridge
Posted on: May 3, 2021

Job Description:

Company DescriptionInfotree's approach to every employee and customer is based around making a positive impact. We focus on over-servicing, continuous improvement and a high-quality culture. We're passionate about making successful matches for our employees and customers across the globe. Infotree prides itself in our proven track record and innovative culture with 100% focus on the employees and customersJob DescriptionPlease rush your resumes at [email protected] or feel free to reach me at 315-524-0230Key skills--- Unless there is sterile, vial, lyo, investigation, tech transfer, drug product in the profile, they likely won't be suitable. --- If the person is more of a project manager than engineer/scientist, they likely won't be suitable.--- Need to show demonstrated technical ability and investigation ability/experience. So far too broad in management rolesJob Description:--- Lead tech transfers--- Lead complex global investigations--- Write and update filings for technical CMC sections--- Collaboration/interpersonal skills to work in matrix environment where establishing relationships with outside Boston stakeholders is key to being effective.OBJECTIVES/PURPOSE (3-4 bullets)--- Provide technical expertise within the GMSci DP/Pkg organizations relating to manufacturing technology and sciences for drug product manufacturing.--- Develops expertise via initial assignments and training with the eventual goal of being an SME for leading major technical transfer or validation projects relating to new product introduction or life cycle management of existing products--- Provides leadership for regulatory interactions including CMC content for dossiers--- Ensures process knowledge is shared and leveraged across sites and functionsACCOUNTABILITIES (Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 - 10 bulleted task statements should be identified).--- Develops expertise to become on small molecule OSD and/or parenterals process and technologies--- Assist the following activities, along with Pharmaceutical Sciences and/or Operation Units:o Drug Product Manufacturing Process Characterization,o Technology Transfer to both CMOs or internal manufacturing facilities,o Drug Product manufacturing and packaging process validationo Serves as the experts for deployment as rapid response teams to serve all local manufacturing Operating Units--- Execute technical tasks , both development and commercial, to support Global Manufacturing Sciences DP and Packaging Science activities--- Implement (AD/Sr Mgr) provide input (Sr Professional) or provide assistance to senior staff members (Professional) for strategies for the continuous improvement on the manufacturing of Marketed Products (a.k.a. matured products) in the late phase of the product life cycle (N/A Professional)--- Implement (AD/Sr Mgr) provide input (Sr Professional) or assist senior members (Professional) the manufacturing strategy for key Client products at internal manufacturing network and CMOs (N/A Professional)--- Acccountable for successful collaboration witho Other functions within GMSo Manufacturing Science Operating Unit staffo Pharmaceutical Sciences counterpartso Other key functional groups such as Global Quality, Regulatory CMC, etc.QualificationsDIMENSIONS AND ASPECTSTechnical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)--- Develops expertise to become SME for Client drug product GMSci organization and network--- In depth and broad (AD), solid (Sr Mgr), basic (Sr Professional, Professional) understanding of drug product manufacturing technologies for solid oral dosage form and/or injectible products--- Knowledge of industry's best practice and innovative/emerging technology with manufacturing of drug product (AD). Good grasp (Sr Professional), Acquiring (Professional) of industry's standard practices.Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)--- Ability to influence within the organization, specifically with Pharmaceutical Sciences, GMS Operating Units and CMOs to drive decisions, alignment, and conflict resolution for complex cross-functional issues--- Effectively communicate and implement innovative and emerging technology for drug product within the Manufacturing Sciences organization.--- Able to communicate and influence decisions of Pharmaceutical Sciences development organizationDecision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)--- Able to independently make complex and key decisions impacting drug product manufacturing ogranzations (AD). Able to make decisions impacting the organization upon consultation with senior management (Sr. Mgr). With appropriate guidance, able to implement the decisions (Sr Professional, Professional)Interaction (The span and nature of one's engagement with others when performing one's job, internal and external relationships)--- Active engagement with development product implementation prior to commercialization to ensure successful commercialization of key Client products.--- Actively partner with local Manufacturing Science lead/reports to ensure consistent application of best technology practices across Client networkInnovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)--- Ensures process knowledge sharing across sites and functions for effective management of products--- Maintain current industry leading technology knowledge, scientific approach and regulatory strategies--- Ability to drive and implement innovative technology at Local Manufacturing Science organizationsComplexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)--- Manages with a matrix of reporting lines and across functional areas--- Provides leadership to drive highly complex projects including that span multiple sites and productsEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)Education / experience--- BS or graduate degree in Chemistry, Chemical Engineering, or other related discipline with 15+ (AD), 10+ (Mgr), 5 (Sr Professional), 0 to 2 (Professional) years of industrial experience or equivalent.--- Minimum 5 (Mgr) years experience in pharmaceutical development and manufacturing--- Previous experience in serving as a SME lead in a matrix environment relating to drug product manufacturing. (N/A Professional level)Skills--- Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.Behaviors--- Focusing on the few priorities and provide superior results--- Elevating capabilities for now and the futureAdditional InformationAll your information will be kept confidential according to EEO guidelines.

Keywords: Infotree Service Inc, Cambridge , CMC Project Manager_technology transfer_Bio-Pharmaceutical industry, Healthcare , Cambridge, Massachusetts

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