Senior Manager Product Development
Apply NowCompany: Unifin SAS
Location: Rochester, NY 14609
Description:
Senior Manager Product Development
Who we are?
We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients' lives to as many people as possible.
With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.
Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 280 employees.
Your role
Reporting to the GENERAL MANAGER NORTH AMERICA,
JOB SUMMARY:
This position is responsible for leading ourdrug product development team to meet the needs of customers, their projects,and commercial production. This positionis responsible for ensuring that activities are performed within an appropriatelevel of cGMP, HS&E and DEA compliance. Development project scope ranges from pre-formulation through commercialfor OTC, generic and brand products across dosage forms including Blow-Fill-Seal,oral liquids and oral liquid stick packs, oral solids, extended-release and resin-complexation. Also responsible for manufacture andpackaging of ICH stability batches, commercial formulation development &optimization, scale-up, commercial process development & optimization,technology transfer, preparation of documentation for regulatory filing andinput for commercial validation. Responsibilities include management of the pilot plant in a c-GMP compliant state for theabove-mentioned activities. Additionally, this position will have responsibility for overall projectmanagement of new and ongoing projects across development functions. These responsibilities include, but are notlimited to, planning, leading, resourcing all aspects of cross-functionalprojects from development through commercialization. Project activities aresupported through matrixed resources, and the position ensures close and opencommunication within the site and with customer representatives.
ESSENTIAL FUNCTIONS / RESPONSIBILITIES:
Capital Projects AchieveIdentified Goals
Develops annual and long range department budgets for both capital and expense spending.
Responsible for the delivery of all major capital projects on the Rochester site. Project execution includes; development of business cases and requests for funding, development of specifications and designs, development of project plans, bidding and award of bids, construction management, and commissioning and qualification.
ImprovedOrganizational Capabilities
Pipeline of Leadership Talent in Key Roles: Analyzes the skills and capabilities of the functional area; identifies future workforce requirements; and identifies a means to close any gaps. Ensures processes are in place for unleashing the full potential of others by providing needed resources, coaching, experiences and other support to place the right people in key roles and continuously upgrade their skills and knowledge.
Organizational Structure: Develops an organizational structure that supports the retention and development of staff to deliver a high level of services, as well as offers career development for high performers/ high potentials.
Employees Aligned to Vision, Direction and Goals: Aligns priorities with the direction and priorities of the broader organization. Diagnoses whether assigned functional areas are performing at full potential and ensures communication cascades down through the organization. Breaks down organizational silos, bridges communication gaps, and engages the employees they manage so the entire workforce can understand how the company operates and how each person can contribute to the company's success.
Champion Change; Innovation: Ensures an environment that encourages fresh perspectives, innovative, breakthrough ideas and new paradigms that create value in the marketplace. Initiates, sponsors, and implements organizational change.
SustainableOperational Improvements
Developsand implements improvement plans to create operating efficiencies, eliminateredundancies, and improve business results. Ensures processes are documentedand standardized.
Utilizesinternal and external data to make analytical observations and recommendationsthat addresses the implications of policy changes, new business strategies; thecompetitive environment; changing demographics; and other trends that impactorganizational performance.
Identifiesthe impact of technology on business processes to ensure that it is used tomaximum advantage in enabling process analysis, decision-making andreporting. Involves employees whenimplementing new technology and ensures they receive necessary training andfollow-through.
Ensuresthe application of a system for achieving and sustaining success throughcustomer focus, process management and improvement, and the wise use of factsand data. The primary goals shall befocused around metrics to validate efficiency, adding to margins and growth ofthe business.
Customers areConfident in the Company's ability to Deliver Products
Collaboratesas the primary liaison within the organization between Business Development,Supply Chain, Operations, and QA to ensure development plans for new businessopportunities and products within Product Development, Validation andEngineering.
Supportsthe accomplishment of company objectives and specifically is able to providethe "Big Picture" analysis/advice in regards to products, processes andprograms.
Ensuresthe effective documentation, transfer and sharing of product and formulationknowledge across the Product Development, Validation and Engineeringorganization.
Overseesprocess development and regulatory compliance strategy and directs productdevelopment programs.
Providesleadership and support for the successful achievement of all new businessinnovation initiatives and programs to assure successful transition to productcommercialization. Confers withcustomers to resolve technical issues, as required.
Ensuresapplication of effective project management methodologies; and organizescross-functional teams to support delivery of product development activities.
Innovations thatare aligned with Business Goals
Researches,evaluates and recommends potential development strategies that build on theorganization's core capabilities to drive growth in current customer businessas well as identify targets for new business.
Identifiesand drives implementation of opportunities for manufacturing efficiency and/orproduct cost savings through cost benefit analysis techniques (ingredientsubstitutions, etc.). Ensures anyproduct risks are mitigated.
Recommendsmethods for improving implementation by reducing wasted materials, andutilizing reorganization of work flow.
Supportsthe means to improve laboratory productivity via enhancements to systems,processes, training, staff development and the implementation of new laboratorytechnologies.
New CommercialProducts Implemented
Evaluatestechnical ability to deliver new business. Oversees the compilation of allscope, resource, and cost information for new products. Applies manufacturingand statistical methods to estimate manufacturing requirements, potential, andcost of product to be developed.
Overseesthe development of product formulations that utilize effective manufacturingprocesses and ensure product safety.
Accountablefor ensuring delivery of product development (e.g. products, methods andprocesses) outcomes consistent with customer agreements. Defines critical milestones, deliverables andto affect final outcome.
ProductionSystems Function as required to meet company goals
Providesand maintains any and all equipment and facilities at the Rochester site,required to support the business plan. This includes maintenance of all existing buildings and equipment and,when required, constructing new facilities or purchasing additionalequipment. This position is alsoresponsible for any alteration or renovation of facilities.
Participatesin strategic and tactical planning and analysis and provide Engineeringsolutions to support the US business plan.
Establishesand maintain systems, which are in compliance with regulatory agencies thatprovide for proper maintenance of equipment and facilities and provide a basisfor recording and archiving all information relative to those maintenanceactivities as required by cGMPs.
Ensuresthat all facilities, equipment, and systems are in full compliance with allapplicable laws and regulations including Federal, State, local, andInternational, including all regulations relative to the production of drugproducts, handling and storage of controlled substances, environmental, andlife safety.
New Commercial ProductsImplemented
Leads customer conference calls, provides project updates, coordinates information flow, coordinates resource, resolves issues between customer and company, and tracks project deliverables, scope and schedules.
Maintains direct involvement with other departments within Unither to help develop specifications, contribute information for GMP related documentation including investigations, batch records and reports and translates contract requirements for Unither departments.
Provides appropriate manufacturing capability and technical support as needed to ensure the success of new product development initiatives, including the manufacture and packaging of clinical supplies.
Manages complex, multidisciplinary projects including project spending and project scope changes to ensure that required deliverables are realized within approved spending limits.
Develops detailed project plans, budgets and timelines using project management tools such as Microsoft Project, and coordinates and ensures timelines with other departments (QA/Validation, Engineering, Operations, external resources, etc.)
Ensures that team members understand and are committed to their specific objectives and to the ultimate goal of the project(s).
Identifies project roadblocks early in the process and brings any areas of conflict with respect to resource allocation (budgets, manpower) to resolution. Insures resolution of cross-functional issues within the project team. When no resolution can be reached, ensures that issues are promoted.
Closely monitors the status and results of all activities carried out under the project plan(s). Keeps plans up-to-date and ensures discrepancies are being resolved.
Prepares project status reports by collecting, analyzing, and summarizing information and trends; recommending actions.
Provides technical leadership on project teams and task groups, ensuring scientifically valid outcomes.
Process development and optimization including scale-up for commercialization.
Smooth and on time technology transfer.
Supports in process validation activities.
Establishes and justifies all specifications for new raw materials and new products.
Skills & Performance ofPeople Are Appropriate for Business Needs
Ensures self and staff understand the organization's vision, values, goals and strategies and their relationship to their daily work.
Manages employee performance by clearly defining job responsibilities and standards of performance; tracking progress against goals; providing clear, thorough, timely feedback; and addressing performance problems and issues promptly.
Helps others to successfully manage organizational change. Facilitates the implementation and acceptance of change within the workplace. Acts as a champion for change. Develops, plans, and follows through on change initiatives. Accepts the ambiguity that comes with change activities.
Understands HR policies and practices and uses them to manage employees.
Ensures money, technology, and staff are allocated to achieve optimal results.
Ensures self and staff keep up-to-date on technical knowledge and developments that impact roles. Uses this information to drive improvements and/or prepare for changing requirements.
Ensures an effective learning environment
Your profile
EDUCATION & EXPERIENCE:
Bachelor's degree required; Masters preferred
Minimum of 12 years of experience in pharmaceutical development, including strong background in drug product development for OTC's, ANDA's and NCEs (BFS, oral liquids, liquid stick pack, oral solids, extended-release, resin-complexation dosage forms ) in early and late stage of the development including formulation and process development experience and proven track record for successful hand-over to commercial production.
Experience in development of drug products.
Experience with transitioning development processes into manufacturing scale.
Areas of expertise should include most, if not all of the following: regulatory affairs and compliance, quality assurance and controls, validation, technical services, and an in-depth knowledge of at least one scientific field related to pharmaceutical sciences.
Project planning and project management experience is required.
Previous supervisory experience is required.
KNOWLEDGE SKILLS & ABILITIES:
Must be knowledgeable in regulatory and technical requirements of the pharmaceutical industry and have a strong management background, including hands-on management of pharmaceutical laboratory.
Will lead cross functional project teams. Must have strong managerial, organization, leadership and analytical skills.
Must have the ability to evaluate resource needs.
Skilled Project Manager.
Exceptional communication skills.
Broad knowledge and technical skills in drug development, clinical manufacturing and commercialization process.
Have a strong understanding and in-depth knowledge of drug/method development, scale up and commercialization.
Successful track record of delivering projects/programs on schedule and within budget.
Demonstrated situational leadership skills (e.g. teambuilding, facilitation, conflict resolution, persuasion, negotiation).
Demonstrated ability to deal effectively across multiple functional departments in a matrixed product team structure.
Demonstrated success in building and running strong, high-performing teams.
Presentation abilities to technical and management teams
The ability to read, write and communicate in English.
Compensation range
125 000,00 - 150 000,00 USD
*The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hour
Who we are?
We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients' lives to as many people as possible.
With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.
Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 280 employees.
Your role
Reporting to the GENERAL MANAGER NORTH AMERICA,
JOB SUMMARY:
This position is responsible for leading ourdrug product development team to meet the needs of customers, their projects,and commercial production. This positionis responsible for ensuring that activities are performed within an appropriatelevel of cGMP, HS&E and DEA compliance. Development project scope ranges from pre-formulation through commercialfor OTC, generic and brand products across dosage forms including Blow-Fill-Seal,oral liquids and oral liquid stick packs, oral solids, extended-release and resin-complexation. Also responsible for manufacture andpackaging of ICH stability batches, commercial formulation development &optimization, scale-up, commercial process development & optimization,technology transfer, preparation of documentation for regulatory filing andinput for commercial validation. Responsibilities include management of the pilot plant in a c-GMP compliant state for theabove-mentioned activities. Additionally, this position will have responsibility for overall projectmanagement of new and ongoing projects across development functions. These responsibilities include, but are notlimited to, planning, leading, resourcing all aspects of cross-functionalprojects from development through commercialization. Project activities aresupported through matrixed resources, and the position ensures close and opencommunication within the site and with customer representatives.
ESSENTIAL FUNCTIONS / RESPONSIBILITIES:
Capital Projects AchieveIdentified Goals
Develops annual and long range department budgets for both capital and expense spending.
Responsible for the delivery of all major capital projects on the Rochester site. Project execution includes; development of business cases and requests for funding, development of specifications and designs, development of project plans, bidding and award of bids, construction management, and commissioning and qualification.
ImprovedOrganizational Capabilities
Pipeline of Leadership Talent in Key Roles: Analyzes the skills and capabilities of the functional area; identifies future workforce requirements; and identifies a means to close any gaps. Ensures processes are in place for unleashing the full potential of others by providing needed resources, coaching, experiences and other support to place the right people in key roles and continuously upgrade their skills and knowledge.
Organizational Structure: Develops an organizational structure that supports the retention and development of staff to deliver a high level of services, as well as offers career development for high performers/ high potentials.
Employees Aligned to Vision, Direction and Goals: Aligns priorities with the direction and priorities of the broader organization. Diagnoses whether assigned functional areas are performing at full potential and ensures communication cascades down through the organization. Breaks down organizational silos, bridges communication gaps, and engages the employees they manage so the entire workforce can understand how the company operates and how each person can contribute to the company's success.
Champion Change; Innovation: Ensures an environment that encourages fresh perspectives, innovative, breakthrough ideas and new paradigms that create value in the marketplace. Initiates, sponsors, and implements organizational change.
SustainableOperational Improvements
Developsand implements improvement plans to create operating efficiencies, eliminateredundancies, and improve business results. Ensures processes are documentedand standardized.
Utilizesinternal and external data to make analytical observations and recommendationsthat addresses the implications of policy changes, new business strategies; thecompetitive environment; changing demographics; and other trends that impactorganizational performance.
Identifiesthe impact of technology on business processes to ensure that it is used tomaximum advantage in enabling process analysis, decision-making andreporting. Involves employees whenimplementing new technology and ensures they receive necessary training andfollow-through.
Ensuresthe application of a system for achieving and sustaining success throughcustomer focus, process management and improvement, and the wise use of factsand data. The primary goals shall befocused around metrics to validate efficiency, adding to margins and growth ofthe business.
Customers areConfident in the Company's ability to Deliver Products
Collaboratesas the primary liaison within the organization between Business Development,Supply Chain, Operations, and QA to ensure development plans for new businessopportunities and products within Product Development, Validation andEngineering.
Supportsthe accomplishment of company objectives and specifically is able to providethe "Big Picture" analysis/advice in regards to products, processes andprograms.
Ensuresthe effective documentation, transfer and sharing of product and formulationknowledge across the Product Development, Validation and Engineeringorganization.
Overseesprocess development and regulatory compliance strategy and directs productdevelopment programs.
Providesleadership and support for the successful achievement of all new businessinnovation initiatives and programs to assure successful transition to productcommercialization. Confers withcustomers to resolve technical issues, as required.
Ensuresapplication of effective project management methodologies; and organizescross-functional teams to support delivery of product development activities.
Innovations thatare aligned with Business Goals
Researches,evaluates and recommends potential development strategies that build on theorganization's core capabilities to drive growth in current customer businessas well as identify targets for new business.
Identifiesand drives implementation of opportunities for manufacturing efficiency and/orproduct cost savings through cost benefit analysis techniques (ingredientsubstitutions, etc.). Ensures anyproduct risks are mitigated.
Recommendsmethods for improving implementation by reducing wasted materials, andutilizing reorganization of work flow.
Supportsthe means to improve laboratory productivity via enhancements to systems,processes, training, staff development and the implementation of new laboratorytechnologies.
New CommercialProducts Implemented
Evaluatestechnical ability to deliver new business. Oversees the compilation of allscope, resource, and cost information for new products. Applies manufacturingand statistical methods to estimate manufacturing requirements, potential, andcost of product to be developed.
Overseesthe development of product formulations that utilize effective manufacturingprocesses and ensure product safety.
Accountablefor ensuring delivery of product development (e.g. products, methods andprocesses) outcomes consistent with customer agreements. Defines critical milestones, deliverables andto affect final outcome.
ProductionSystems Function as required to meet company goals
Providesand maintains any and all equipment and facilities at the Rochester site,required to support the business plan. This includes maintenance of all existing buildings and equipment and,when required, constructing new facilities or purchasing additionalequipment. This position is alsoresponsible for any alteration or renovation of facilities.
Participatesin strategic and tactical planning and analysis and provide Engineeringsolutions to support the US business plan.
Establishesand maintain systems, which are in compliance with regulatory agencies thatprovide for proper maintenance of equipment and facilities and provide a basisfor recording and archiving all information relative to those maintenanceactivities as required by cGMPs.
Ensuresthat all facilities, equipment, and systems are in full compliance with allapplicable laws and regulations including Federal, State, local, andInternational, including all regulations relative to the production of drugproducts, handling and storage of controlled substances, environmental, andlife safety.
New Commercial ProductsImplemented
Leads customer conference calls, provides project updates, coordinates information flow, coordinates resource, resolves issues between customer and company, and tracks project deliverables, scope and schedules.
Maintains direct involvement with other departments within Unither to help develop specifications, contribute information for GMP related documentation including investigations, batch records and reports and translates contract requirements for Unither departments.
Provides appropriate manufacturing capability and technical support as needed to ensure the success of new product development initiatives, including the manufacture and packaging of clinical supplies.
Manages complex, multidisciplinary projects including project spending and project scope changes to ensure that required deliverables are realized within approved spending limits.
Develops detailed project plans, budgets and timelines using project management tools such as Microsoft Project, and coordinates and ensures timelines with other departments (QA/Validation, Engineering, Operations, external resources, etc.)
Ensures that team members understand and are committed to their specific objectives and to the ultimate goal of the project(s).
Identifies project roadblocks early in the process and brings any areas of conflict with respect to resource allocation (budgets, manpower) to resolution. Insures resolution of cross-functional issues within the project team. When no resolution can be reached, ensures that issues are promoted.
Closely monitors the status and results of all activities carried out under the project plan(s). Keeps plans up-to-date and ensures discrepancies are being resolved.
Prepares project status reports by collecting, analyzing, and summarizing information and trends; recommending actions.
Provides technical leadership on project teams and task groups, ensuring scientifically valid outcomes.
Process development and optimization including scale-up for commercialization.
Smooth and on time technology transfer.
Supports in process validation activities.
Establishes and justifies all specifications for new raw materials and new products.
Skills & Performance ofPeople Are Appropriate for Business Needs
Ensures self and staff understand the organization's vision, values, goals and strategies and their relationship to their daily work.
Manages employee performance by clearly defining job responsibilities and standards of performance; tracking progress against goals; providing clear, thorough, timely feedback; and addressing performance problems and issues promptly.
Helps others to successfully manage organizational change. Facilitates the implementation and acceptance of change within the workplace. Acts as a champion for change. Develops, plans, and follows through on change initiatives. Accepts the ambiguity that comes with change activities.
Understands HR policies and practices and uses them to manage employees.
Ensures money, technology, and staff are allocated to achieve optimal results.
Ensures self and staff keep up-to-date on technical knowledge and developments that impact roles. Uses this information to drive improvements and/or prepare for changing requirements.
Ensures an effective learning environment
Your profile
EDUCATION & EXPERIENCE:
Bachelor's degree required; Masters preferred
Minimum of 12 years of experience in pharmaceutical development, including strong background in drug product development for OTC's, ANDA's and NCEs (BFS, oral liquids, liquid stick pack, oral solids, extended-release, resin-complexation dosage forms ) in early and late stage of the development including formulation and process development experience and proven track record for successful hand-over to commercial production.
Experience in development of drug products.
Experience with transitioning development processes into manufacturing scale.
Areas of expertise should include most, if not all of the following: regulatory affairs and compliance, quality assurance and controls, validation, technical services, and an in-depth knowledge of at least one scientific field related to pharmaceutical sciences.
Project planning and project management experience is required.
Previous supervisory experience is required.
KNOWLEDGE SKILLS & ABILITIES:
Must be knowledgeable in regulatory and technical requirements of the pharmaceutical industry and have a strong management background, including hands-on management of pharmaceutical laboratory.
Will lead cross functional project teams. Must have strong managerial, organization, leadership and analytical skills.
Must have the ability to evaluate resource needs.
Skilled Project Manager.
Exceptional communication skills.
Broad knowledge and technical skills in drug development, clinical manufacturing and commercialization process.
Have a strong understanding and in-depth knowledge of drug/method development, scale up and commercialization.
Successful track record of delivering projects/programs on schedule and within budget.
Demonstrated situational leadership skills (e.g. teambuilding, facilitation, conflict resolution, persuasion, negotiation).
Demonstrated ability to deal effectively across multiple functional departments in a matrixed product team structure.
Demonstrated success in building and running strong, high-performing teams.
Presentation abilities to technical and management teams
The ability to read, write and communicate in English.
Compensation range
125 000,00 - 150 000,00 USD
*The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hour