Associate Director, New Product Introductions
This position strategically supports GBT's efforts to expand access to our products by managing the package design and introduction of new products and line extensions to the different markets we serve. The selected candidate will be responsible for leading packaging technology introduction and transfers in our external global packaging network. This Supply Chain role will require close coordination between GBT CMC Leadership, Commercial Operations, Joint Manufacturing Teams, Packaging Engineering, Artworks Management, Quality & Regulatory functions. Successful management of GBT's product portfolio will require prior hands-on experience and measurable achievements launching small and large molecules. Familiarity with emerging technologies like autologous/allogenic gene therapy will be considered a plus. Essential Duties and
Responsibilities:
Establish the successful change management framework to successfully introduce new packaged products into existing and new global markets Work with project managers to determine the necessary work break down activities in the areas of package design, product labeling, packaging components selection, transport qualification, packaging process validation and go-live activities Evaluate fit-for-use packaging process capabilities at external packaging partners and determine best application of site assets Own GMP change control process for each project Oversee and manage packaging engineering and development activities, including component design, selection and specification Oversee and manage technical transfer activities at external packaging partner Oversee label development activities from master label receipt through implementation at site Oversee validation exercises at external packaging partners Provide timely identification and escalation of at-risk milestones using business tools (eg:
Gantt charts, trackers, risk assessments, etc.) and drive remediation or mitigation activities Develop knowledge for the organization and share the gained know-how with team members Provide technical mentorship to other GBT colleagues and stakeholders
Qualifications:
B.A./B.S. degree, preferably in engineering or natural sciences 7
years working in new product introductions and packaging operations in Biotech/Pharma Project management skills and experience in cross-functional projects Experienced in the qualification of packaging machinery and associated process control/automation tools Experienced in the validation of packaging processes Experienced managing change control records under applicable current Good Manufacturing Practices Ability to develop relationships and interact effectively with all levels of customer and supplier organizations, demonstrating an excellent customer mindset in interfacing with internal departments and suppliers Experience in mentoring/coaching team members Good organizational skills, a strong attention to detail, and an ability to prioritize tasks within a busy environment Ability to work under time constraints and meet deadlines Proficiency in MS Office, primarily Excel required Excellent written and verbal communication skills Approximately 5-20% travel may be required Fit with GBT culture:
Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE:
This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization
Salary Range:
$100K -- $150K
Minimum Qualification
Other SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Establish the successful change management framework to successfully introduce new packaged products into existing and new global markets Work with project managers to determine the necessary work break down activities in the areas of package design, product labeling, packaging components selection, transport qualification, packaging process validation and go-live activities Evaluate fit-for-use packaging process capabilities at external packaging partners and determine best application of site assets Own GMP change control process for each project Oversee and manage packaging engineering and development activities, including component design, selection and specification Oversee and manage technical transfer activities at external packaging partner Oversee label development activities from master label receipt through implementation at site Oversee validation exercises at external packaging partners Provide timely identification and escalation of at-risk milestones using business tools (eg:
Gantt charts, trackers, risk assessments, etc.) and drive remediation or mitigation activities Develop knowledge for the organization and share the gained know-how with team members Provide technical mentorship to other GBT colleagues and stakeholders
Qualifications:
B.A./B.S. degree, preferably in engineering or natural sciences 7
years working in new product introductions and packaging operations in Biotech/Pharma Project management skills and experience in cross-functional projects Experienced in the qualification of packaging machinery and associated process control/automation tools Experienced in the validation of packaging processes Experienced managing change control records under applicable current Good Manufacturing Practices Ability to develop relationships and interact effectively with all levels of customer and supplier organizations, demonstrating an excellent customer mindset in interfacing with internal departments and suppliers Experience in mentoring/coaching team members Good organizational skills, a strong attention to detail, and an ability to prioritize tasks within a busy environment Ability to work under time constraints and meet deadlines Proficiency in MS Office, primarily Excel required Excellent written and verbal communication skills Approximately 5-20% travel may be required Fit with GBT culture:
Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE:
This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization
Salary Range:
$100K -- $150K
Minimum Qualification
Other SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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