Our Human Health Division maintains a patient first, profits later ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide.
Our Oncology team is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide.
Our team of forward-thinking individuals achieve this through an unwavering commitment to support accessibility to medicine, providing new therapeutic solutions, and collaborating with governments and payers to ensure that people who need medicines have access to them.
Our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe.
We are continually striving to improve the understanding of health care within the local community. Our site in 1220 Vienna is a strategic location for the distribution of our high quality and innovative health care products, as well as digitally integrated solutions for our patients and clients.
To ensure sustainable company growth, we continually aim to offer attractive career opportunities for our employees at our Vienna site.
In support of our existing team we are currently looking for the position of :
Associate Director Engineering Large Molecule (m / f / d)
The Associate Director will be the key technical leader interface between our company and External Partners for the Large Molecule (Biologics / Vaccines / Sterile) External Manufacturing (ExM) organization.
This individual will create, lead and execute technical transfers to and commercial supply from External Partner(s). The candidate will be based in the EU and report to the Director, Large Molecule (LM) External Manufacturing Technology.
The ideal candidate will be someone who can navigate a complex network of drug substance and / or drug product nodes across vaccines and / or biologics modalities and tech support models.
The candidate needs to collaborate across multiple technical functions to ensure the success technical transfer and commercial manufacture with the External Partner(s).
This individual will be capable of leading several high-impact, complex, cross-functional divisional teams and will provide significant leadership to the department.
This role is critical to the organization’s ability to support new and in-line commercial product technology transfers to External Partnerships, and support of our in-line products, with sharp oversight and technical risk management, focus on the rapidly expanding biologics and vaccines third party network.
Provides a single point of technical contact to assigned External Partners, impacted our Manufacturing sites, and Commercialization
Provides technical oversight, management, and planning support for complex partnership models. Functions independently and provides coordination, communication, and oversight of assigned External Partner technical issues
Accountable to External Manufacturing for overall tech transfer delivery (on-time, within budget), working closely with the Operations Unit leadership to assure resourcing for each activity
Provides technical guidance to the External Partner, assess viability of technology in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound
Collaborates with Procurement, External Manufacturing Operations, External Quality, Regulatory and others to evaluate External Partner(s) for inclusion in our company Network.
Executes technical due diligence assessments at External Partner(s)
Ensures tech transfers are positioned for successful business outcomes. Executes technical transfers and receiving site readiness activities
Leads team for identification and assessment of partner risks and develops mitigations plans
Develops and executes validation strategies for new and existing products
Provides manufacturing process support to External Partner(s) to resolve production issues and to provide guidance on process and capacity optimization
Ensures targeted communications and alignment across technical functions. Guides and coaches’ others in change leadership
Support / Coordinate / Manage complex investigations, with appropriate interface with other impacted manufacturing sites
Determines resource plans across all relevant technical functions
Provides a technical review of External Partner process change requests, deviations, and Master Batch Record changes. Minimizes duplication of efforts between External Partner and our systems
Drive and support Continuous process verification and process performance monitoring program for all products under his / her responsibility
In concert with Commercialization, Quality, and Regulatory, ensures that External Partner(s) are inspection ready for all new product introductions and transfers
Understands the true regulatory requirements and partners with Operations, Quality, and the External Partner to develop more efficient ways to meet these requirements
Collaborates with External Partners to achieve business goals and to establish a common culture that benefits both our company and EP
Education Requirements :
A Bachelor’s degree in Engineering or applicable Science is required. An advanced degree in Engineering, Science, or Business is preferred.
Solid post-bachelor’s degree experience in Drug Substance and / or Drug Product vaccines and / or biologics manufacturing, engineering, and / or technical support of operations is required.
Skill Requirements :
Expertise and demonstrated accomplishments leading technical transfers is required
Experience in leading cross-functional teams in support of manufacturing operations at internal sites or External Partner(s) is preferred
Expertise and demonstrated accomplishments with Lean Manufacturing applications to ensure year on year productivity improvements is preferred
Advanced problem-solving skills and experience leading teams to resolve complex business or technical issues is required
Excellent leadership, collaboration, change management, interpersonal, analytical skills, collaboration, and engagement as a team player with dependable interpersonal and communication skills (both verbal and written) is required
Ability to motivate a team around a common vision and deliver expected results is preferred
Creative, innovative, thinks outside of the box, self-motivated, applies problem-solving skills, and solid base in engineering fundamentals and process troubleshooting is preferred
Experience in complex international environment with matrix organization structures is preferred
Experience in Large Molecule unit operation design, startup, and / or operation is preferred.
We offer an attractive salary, outstanding social benefits and an exciting work environment with varied tasks in an international environment.
The minimum annual salary for this position is EUR 64.600, and varies according to the qualifications and experience of the successful candidate.
We are looking forward to receiving your application.
Who we are
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as Merck in the United States, Canada & Puerto Rico. We are known as MSD in Europe, Middle East, Africa, Latin America & Asia Pacific.
We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers.
We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come.
We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.