Location: Gaithersburg, MD
Company: Astrazeneca
Management & Executive Jobs refer to positions within an organization that involve overseeing operations, making strategic decisions, and leading teams or entire companies towards their objectives. These roles typically require a mix of leadership skills, industry experience, and strategic thinking. Executives and managers are often responsible for setting goals, organizing resources, managing personnel, and ensuring that their department or organization meets performance targets. Distinctive characteristics of these jobs include high responsibility, decision-making authority, and frequently, a corresponding higher level of compensation reflecting their critical role in an organization's success.
Management & Executive Jobs refer to positions within an organization that involve overseeing operations, making strategic decisions, and leading teams or entire companies towards their objectives. These roles typically require a mix of leadership skills, industry experience, and strategic thinking. Executives and managers are often responsible for setting goals, organizing resources, managing personnel, and ensuring that their department or organization meets performance targets. Distinctive characteristics of these jobs include high responsibility, decision-making authority, and frequently, a corresponding higher level of compensation reflecting their critical role in an organization's success.
Management & Executive Jobs refer to positions within an organization that involve overseeing operations and making strategic decisions to guide the company towards its objectives. These roles are characterized by leadership responsibilities, high-level planning, and typically require extensive experience. Executives set the vision and goals, while managers ensure that daily activities align with these directives. Such positions often demand strong communication and interpersonal skills, as well as the ability to solve complex problems and adapt to changing business environments.
big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person. About Astra Zeneca in Gaithersburg, MD : Our Gaithersburg, Maryland facility crafts life-changing medicines for people around the world.
This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most groundbreaking technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees
benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration. The Gaithersburg site offers a variety of amenities to help boost efficiency and help keep our employees happy and healthy.
This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you'll find newly-designed, activity-based work spaces to suit a variety of working styles while growing collaboration between teams. Summary of the group: As an Associate Director, Analytical Sciences in Gaithersburg, MD you'll play a pivotal role in channeling our scientific capabilities
to make a positive impact on changing patients' lives. We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it.
We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the Astra Zeneca family, as together we explore synergies between small and large molecules.
Astra Zeneca has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent. Main Duties and Responsibilities Direct a team of scientists conducting analytical development of biomedical drug candidates from clinical development through registration. Represent Analytical Sciences at CMC teams. Lead analytical matrix team, establish development plan and timeline to meet CMC team needs. Lead product characterization, CQA backssment, method development/optimization, setting scientifically justifiable comparability strategies, specification and control strategies.
Author, review and/or approve key documents such as: comparability protocols and reports, justification of specifications, and relevant sections of regulatory filings (IND, IMPD, BLA, etc. ). Lead cross-functional team to develop business processes and guidelines for integrated early and late stage analytical development activities in support of biologics commercialization. Essential Requirements A degree in chemistry, biochemistry or related field with relevant experience. BS with 15+ yrs experience MS with 13+ yrs experience Ph D with 7+ yrs experience Desirable Requirements Significant and established experience in the biomedical industry with relevant experience in late stage product characterization, risk backssment, method development, optimization, validation, regulatory filing, and response to agency questions.
Theoretical and hands on knowledge with methods used for biomedical characterization including mass spectrometry, liquid chromatography, electrophoresis and other physicochemical technologies. Experience with regulatory submissions (IND, BLA, MAA, JNDA). Deep understanding of regulatory requirements for development and commercialization of biomedicals.
Experience leading/developing staff members. Provide technical advice to analytical scientists and associates, where needed, to assure the highest quality of data is developed and presented. Why Astra Zeneca? At Astra Zeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-medical company can be.
This means we're opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility.
Join us in our unique and ambitious world. " So, what's next! Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours. Where can I find out more? Our Social Media, Follow Astra Zeneca on Linked In /company/1603/ Follow Astra Zeneca on Facebook /astrazenecacareers/ Follow Astra Zeneca on Instagram /astrazeneca_careers/? hl=en Date Posted 27-Dec-2023 Closing Date Our mission is to build an inclusive and equitable environment. We want people to feel they belong at Astra Zeneca and Alexion, starting with our recruitment process.
We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. Astra Zeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
The Director, External Supply role is a highly visible hands-on position that will have sole responsibility for managing all aspects of Emergent’s external manufacturing partners accountable for end-to-end supply chain and customer fulfilment supporting both Commercial and Medical Countermeasure Business Lines.
Works closely with Quality, S&D, Technical Operations, Regulatory Affairs, and Sales Operations delivering on our commitments and exceeding Customer expectations while upholding Emergent’s high level of customer service, compliance standards and product requirements. Using Operational Excellence principles, develops strategic plans to improve productivity, quality, and efficiency
of operations. II. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. • Accountable for end-to-end supply chain of Externally Manufactured Products and the development / maintenance of the operational model ensuring a compliant and cost-effective system for both domestic and international partners.
• Demonstrate strong business acumen interfacing with site and corporate positions within the organization including C-level, understanding customers’ needs and formulate effective solutions exceeding expectations • Implement processes to monitor system health AND report performance metrics related to cost,
quality, service, and safety. • Coordinate efficient implementation of product/process changes at contract sites and efficient coordination between external manufacturers and Project Management / Product Development • Seek input to provide recommendations and formulate action plans for open issues based on industry best practices and hold issue owners accountable to hitting delivery targets • Represent business at S&OP and S&OE meetings providing supply analysis, options, mitigations and recommendations to address any supply chain gaps within the portfolio • Provide assistance with capital projects involving modifications at external manufacturers for new capabilities and manufacturing improvements • Support 3PL and external warehouse activities as necessary to support customer and business demands • Advance EBS’s strategic areas of focus while ensuring a continuous improvement mindset.
Key areas including leadership / employee development, advancement of best-in-class business processes, operational excellence, financial discipline / data driven decision making and quality / compliance • Lead or assist with Global supply chain projects and initiatives as required • Uphold Emergent’s core values, commitment to quality and corporate responsibility The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties.
Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS • Bachelor’s Degree in Supply Chain or Operations Management • 8-10 years of related experience within medical device, combination drug device, biotechnology, medical, or contract manufacturing industry required • Minimum 5 years of Management experience • Ability to work within a matrixed organization • Multiple disciplines in CMO management, aseptic fill operations under c GMP manufacturing, assembly & packaging, distribution both domestic and international • Working knowledge of International distribution regulations and requirements including but not limited to controlled substances, customs documentation, import / export VAT and tax considerations etc.
• Solid understanding of US and European regulations including application in the day-to-day environment • Demonstrated strengths in relationship management that results in optimum service and performance • Effective communicator with strong leadership and interpersonal skills • Strategic and tactical thinking with excellent analytical problem-solving skills • Ability to collaborate with internal and external partners at multiple levels.
• Ability to manage, prioritize and work cross functionally to influence behaviors and gain consensus • Experience in Lean principles and concepts • Hands on experience with SAP preferred Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees.
This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent Bio Solutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.
Emergent does not discriminate on the basis of race, color, creed, religion, interaction or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), interactionual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent Bio Solutions for activities related to your prospective employment.
Emergent Bio Solutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy. Emergent Bio Solutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent Bio Solutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent Bio Solutions by search/recruiting agencies not already on Emergent Bio Solutions’ approved agency list shall become the property of Emergent Bio Solutions and if the candidate is subsequently hired by Emergent Bio Solutions, Emergent Bio Solutions shall not owe any fee to the submitting agency.
