DIRECTOR, LMST DCT LEADER

Job Description DCT Leader Role The Development and Commercial Team leader (DCT) is Accountable to Development Commercialization Review Committee (DCRC) for delivering a fully-integrated stage-appropriate development and commercialization strategy which yields the target commercial product.
Leads DCT.
Critically assesses all team deliverables & fosters a learning and collaborative environment.
Prioritizes, interrogates and mitigates risks across all factors that may impact technical, operational & regulatory success or timelines.
Analyzes and develops innovative solutions to unforeseen circumstances.
Responsible for end-to-end technical product leadership (TPL) and oversight of the on-time execution of DCT deliverables including – robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust commercial supply chain to achieve launch on time and uninterrupted long-term supply.
Responsible to ensure the best science and most robust processes are used, working closely with DCRC.
As the Product TPL takes ownership for the products’ technical processes and associated technical challenges, proactively prioritizing, interrogating and mitigating risks across technical, regulatory and operational factors.
Conducts options analysis and provides recommendation to governance for endorsement.
Represents CMC and effectively communicates across the governance bodies, stakeholders and team.
Drives outcomes/decisions through influence, advocacy, & negotiation with stakeholders.
Influences and challenges the xDT strategy to ensure a robust CMC strategy is achieved.
Identifies options to balance Speed/Cost/Robustness & achieve target commercial product.
Direct the necessary technical reviews, and ensure robust solutions and approaches are developed by working teams supporting the product.
Required to comply with our company's Global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
Work collaboratively to drive a safe and compliant culture in GSEC and within the teams that they interact with.
Educational Background and Experience.
B.
.
/M.
.
/Ph.
.
in one of the relevant Engineering or Science fields.
Minimum of 10 year’s experience in biopharmaceutical manufacturing and/or development, preferably a majority spent in science and technical role.
Experience with product development and new product introduction is required.
Demonstrated expertise in technical aspects and interdependencies across DS, DP, device and analytical, regulatory, quality, and supply chain from early development through to commercial manufacturing.
Demonstrated understanding of connectivity between clinical, CMC, and Human Health (Commercial Organization) to successfully launch a new product.
Ability to navigate through uncertainty to favorable outcomes.
Ability to challenge and influence clinical strategies; effectively communicating CMC perspectives and ensuring enrollment and alignment with clinical development teams (PDT).
Able to operate and provide direction through ambiguity and adapt plans in the face of change, unexpected events, or new information.
Demonstrated functional and enterprise leadership, ability to influence at all levels of the organization, holding and team to high standards.
Provides direct feedback when individuals/governance not meeting expectations.
Drives accountability on team to follow through on commitments, leading to progression of program through milestones according to Governance (DCRC, DTRC, LDRC) expectations.
Holds functions accountable to deliver.
Creates and leads a high performing team, develops team members by working closely with functional leaders.
Demonstrated ability to develop creative and innovative solutions to complex problems, leveraging scientific expertise and growth mindset; fosters environment where DCT members can do the same.
Approaches problem solving and project progression logically and in alignment with overall business needs.
Effective communicator with demonstrated ability to tailor communications to diverse audiences, including governance, senior leadership, team members, stakeholders, and individuals with business and technical backgrounds.
Active listening skills to understand others' perspectives, concerns, and ideas.
Strategic outlook.
Sees the big picture, thinks strategically, and demonstrates a customer orientation – both to the patient and to the long-term recipient of our new product process, methods, supply chain.
Strong collaborative and talent-building skills and the ability to work strategically and in a detail-oriented framework with all levels of management.
Teamwork.
Ability to build and strong relationships with team members, key functional and site leaders, and XDT members to promote effective collaboration.
Ensures a strong team environment for open discussions, enabling all team members to contribute their perspectives and collectively resolve issues.
NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.
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Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated.
Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.
This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely.
Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
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Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range.
$ Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
A summary of benefits is listed here.
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Employee Status.
Regular Relocation.
VISA Sponsorship.
Travel Requirements.
Flexible Work Arrangements.
Not Applicable Shift.
Valid Driving License.
Hazardous Material(s).
Job Posting End Date.
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Job Posting End Date.
A job posting is effective until PM on the day BEFORE the listed job posting end date.
Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID.
R