Senior manufacturing manager job description

This position will report to the Senior Director, Gene Therapy Commercial Manufacturing and will be responsible for oversight of all aspects of manufacturing (make, assess and release) at the CMO to ensure clinical and commercial drug supply needs are met. This also includes oversight of contract deliverables.
This position is located in Maryland and requires 5 days a week on site.

Primary Responsibilities Include:
Participating in the cross-functional working team to support GMP production at CMO partners, including all activities from initial cell banking through bulk drug substance. Building business processes and cross-functional relationships with internal/external partners. This includes applicable metrics and program- tracking. Ensuring that all contractual obligations with our CMOs are met to Sarepta Quality standards, including on-time manufacturing, QC testing, QMS record closure and batch disposition. Authoring and/ or review of Quality System documentation, including technical reports, deviations and change controls. Provide manufacturing technical expertise in meetings related to QMS documentation. Provide front-line support for process or equipment related issues at the CMO and ensure cross-functional engagement internally. This includes person-in plant (PIP) responsibilities.Lead or drive the resolution of major and critical deviation investigations. Partner with Process Development and Quality for tech transfer as well as to qualify and validate the manufacturing processes and QC methods. Review of SOPs, batch records and supporting documentation as needed.

Desired Education and Skills:
Degree in Engineering or Life Sciences, with 8+ years of relevant industry experience.Experience with technology transfer/vendor management and process characterization/ validation preferred.Strong working knowledge of FDA regulations (GMPs) and industry standards. Experience with Gene Therapy or biologics BDS/ DP production. Strong project management and organizational skills. Excellent communication skills and ability to influence across multiple functions. 20% travel anticipated.

Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
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Leading the future in luxury electric and mobility
At Lucid, we set out to introduce the most captivating, luxury electric vehicles that elevate the human experience and transcend the perceived limitations of space, performance, and intelligence. Vehicles that are intuitive, liberating, and designed for the future of mobility.

We plan to lead in this new era of luxury electric by returning to the fundamentals of great design - where every decision we make is in service of the individual and environment. Because when you are no longer bound by convention, you are free to define your own experience.

Come work alongside some of the most accomplished minds in the industry. Beyond providing competitive salaries, we're providing a community for innovators who want to make an immediate and significant impact. If you are driven to create a better, more sustainable future, then this is the right place for you.

We are looking for a Sr. Finance Manager to support Lucid international expansion, partnering with cross function team to develop financial models for business decision. This role will lead couple of finance Supervisor and Sr. Finance Analysts, will report to Finance Director
The Role:Modeling business cases of multiple projects for global manufacturing international expansion, including P/L, cash flow, NPV, IRR analysis Working with cross functional team (Corporate FP&A, Engineering, Purchasing, Manufacturing, Logistics, Program Management and business development) to understand financial inputs and provide financial analysis for business decisions Develop profitability models estimating capital payback periods and rates of return.Present business case to executives in cohesive reports that provide clear communication and recommendations.Additional ad-hoc assignments and projects supporting, including Annual Budget, Cycle Plan, longer-term Business Plan Manage and track multiyear project budget including Opex and Capex
Qualifications:Bachelor's degree in Finance, Accounting or related field Master's degree in Business Administration (MBA) - preferred At least 10 years' relevant experience, including 5 years people management, international assignment is preferred Proven technical, quantitative and critical-thinking skills, high level of independent judgment, initiative and creativity to identify and clearly communicate key performance drivers to senior management Ability to manage multiple projects and assignments with a high degree of autonomy and accountability for results Demonstrated effective written, interpersonal and oral communication skills Established ability using Microsoft Office software with a high proficiency with ExcelFinance analyst experience at an Automotive OEM or Tier 1 Supplier - a huge plus!
At Lucid, we don't just welcome diversity - we celebrate it! Lucid Motors is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, national or ethnic origin, age, religion, disability, sexual orientation, gender, gender identity and expression, marital status, and any other characteristic protected under applicable State or Federal laws and regulations.

Notice regarding COVID-19 protocols
At Lucid, we prioritize the health and wellbeing of our employees, families, and friends above all else. In response to the novel Coronavirus all new Lucid employees, whose job will be based in the United States may or may not be required to provide original documentation confirming status as having received the prescribed inoculation (doses). Vaccination requirements are dependent upon location and position, please refer to the job description for more details.

Individuals in positions requiring vaccinations may seek a medical and/or religious exemption from this requirement and may be granted such an accommodation after submitting a formal request to and the subsequent review and approval thereof by our dedicated Covid-19 Response team.

To all recruitment agencies: Lucid Motors does not accept agency resumes. Please do not forward resumes to our careers alias or other Lucid Motors employees. Lucid Motors is not responsible for any fees related to unsolicited resumes.

City/Cities:
Toronto

Travel Required:

Relocation Provided:
No

Job Posting End Date:
Not Available

Shift:

Job Description Summary:
Position Overview:Position reports to the Director of Supply Chain & Contract Manufacturing and is responsible for all operational aspects of Juice Manufacturing within the Canadian Network for Coca Cola. This role is a key role in ensuring compliance to the contract, tracking usage, as well as being the primary escalation point for operational concerns between the Coman and The Coca-Cola Company. Responsible for all supply chain aspects in resolving Contract Manufacturer operational issues relating to conversion, quality and transportation, inclusive of a Company owned plant in Peterborough. This role will support the innovation initiatives, planning process, on-site implementation, and on time new product launches execution. In addition, lead monthly business performance reviews and track performance trends.Function Related Activities/Key Responsibilities:
Develop and analyze performance data (consumer complaint, order fulfillment, budget variances, production attainment, etc.) to identify business plan variances using established systems and problem-solving methods. Collaborate with Company stakeholders to perform Monthly & Annual Letter Settlement investigations and facilitate alignment with Contract Manufacturer Monitor supply chain metrics and drive overall operational process improvement Production accuracy and PO attainment tracking and improvement Business review / contract management and renewal Budget Management, reporting and audit support Materials/Pallets availability support Downtime reporting and collaboration with various CoMan operations in Canada & The Coca Cola Company Supply Planning to define service impact and resolutions New product launches, commissioning, and operational testing/trials coordination and schedule adherence
Education Requirements:
Bachelor's Degree required. 5+ years of experience in Supply Chain, Manufacturing, Business Operations or related experience
Functional Requirements:
Technical Skills: Knowledge of supply chain capabilities, strategies and interdependencies to perform short and long-term business planning Ability to incorporate strengths, weaknesses, external opportunities and threats into business plan strategies and execution tasks.Knowledge of multiple levels of the supply chain used to analyze contingency points, labor staffing and feedback on Contract Manufacturer capacities.Ability to align the Contract Manufacturer capabilities with the Company strategy and comprehend supply/demand market conditions.Ability to develop contingency plans that meet performance requirements Knowledge of key elements such as raw material costs, economic principles, processing costs and market conditions.Understanding / Familiarity with manufacturing processing equipment and technology (pasteurization, blending mixing, fillers, labelers, palletizers, etc.) Experience in negotiating operating terms in agreements in addition to pricing Understanding / Familiarity with Good Manufacturing Practices (GMPs) and Lean Manufacturing principles Preferred: Power BI experience to support reporting and service metrics capabilities
Travel:
Majority of Co-Manufacturing sites are in the Greater Toronto Area. Approximately 10% Travel.

Skills:

Our Purpose and Growth Culture:

We are taking deliberate action to nurture an inclusive culture that is grounded in our company purpose, to refresh the world and make a difference. We act with a growth mindset, take an expansive approach to what's possible and believe in continuous learning to improve our business and ourselves. We focus on four key behaviors - curious, empowered, inclusive and agile - and value how we work as much as what we achieve. We believe that our culture is one of the reasons our company continues to thrive after 130+ years. Visit Our Purpose and Vision to learn more about these behaviors and how you can bring them to life in your next role at Coca-Cola.