Senior Specialist, Drug Product QC

Description

Are you passionate about analytical chemistry? Do you thrive in a collaborative environment that spans functions and cultures? If so, now is your chance to join the Drug Product QC team in an innovative and fast-growing biotech company as our new Senior Specialist. Ascendis Pharma is a fast-growing global biopharmaceutical company committed to making a meaningful difference in patient’s lives. We have locations in Denmark, Germany, the United States, the UK, Italy, Spain, and France.Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs.Today, we are advancing programs in Endocrinology Rare Disease and Oncology.

In addition, we collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets.We are seeking an experienced Senior Specialist to join our growing team. As a key member of the Ascendis Pharma QC team, you will play a central role in coordinating analytical matters between Ascendis and different Contract Manufacturing Organizations (CMOs) as well as establishing and maintaining oversight over stability studies. You will be involved in all aspects of QC testing and handling of stability studies at our CMOs including validation, trouble shooting, trending and optimization.

As we are currently submitting our products in many countries preparing regulatory documentation and answering questions from different authorities will be a part of the job. So, the success criterion in the job will be to ensure continuous good relations and alignment with CMOs and to ensure that analytical activities are executed according to regulatory requirements and in a scientifically sound manner. You will join the Drug Product QC team of five colleagues and report to Senior Director Lars Bo Ekhart Jensen, based in Hellerup. 

Your key responsibilities will be:

Oversight and coordination of analytical activities at the CMOs

Support the CMOs in decisions regarding the analytical methods e.g. validation strategy, laboratory investigations, method optimization.

Give input or participate directly with the CMO in trouble shooting in connection with adverse events in the laboratory

Planning and follow up on projects initiated at the CMOs

Facilitate and support analytical performance and efficiency improvements

Review and approve analytical documents e.g. laboratory investigations, validations, protocols, reports, and deviations

Support regulatory documentation, follow-up on post-approval commitments and answering regulatory questions on method- and stability related aspects to the authorities
Support our partners in different countries in preparing submission packages for the local authorities

Stay updated with scientific and regulatory development in areas of analytical testing, analytical methods, analytical validation, and stability testing

Contribute to establishing a strong QC organization within Ascendis Pharma

Qualifications and Skills: 

You hold a relevant academic degree – preferably a Master of Science in Chemistry, Engineering, Pharmacy or the like

You have at least 8 years of experience from the pharmaceutical industry within chemical analysis, especially chromatographic methods (HPLC/UPLC, LC-MS, SE-HPLC), either from an Analytical Development Laboratory or from a QC Laboratory.

Furthermore, it is an advantage if you have experience with: 

Collaboration and communication with external stakeholders enabling you to guide project teams at CMOs through conceptual as well as specific practical discussions.

Management of stability programs, generation of protocols and reports, sample management and compilation of results

Key personal competencies: 

You are a strong team player and have a can-do attitude. You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key. To succeed in this role, we expect you to be structured and systematic in your approach to solving tasks. As the job involves many stakeholders and coordination of activities both internally and externally, you thrive on being in contact with new people and you are proficient in English, both written and spoken.  You know how to maintain a constructive working environment and are used to work with stakeholders to support product supply programs and ensure adherence to project timelines.

You enjoy having a broad network and know how to secure an acceptable compliance level at CMOs with different approaches to GMP. You enjoy sharing knowledge and participating actively in projects and cross functional meetings. You are used to establishing overviews, preparing and following plans, and finding smarter ways of doing things are key goals for you.  Travel: 5-15 days per year.  Office: Denmark, Tuborg Boulevard 12, 2900 Hellerup   Apply now  Applications will be evaluated when received, so please apply as soon as possible.  All applications must be submitted in English and are treated confidentially.  For more details about the position or the company, please contact Lars Bo Ekhart Jensen, Sr.

Director, +45 3080 5829, lbej@ascendispharma.com, or visit our website www.ascendispharma.com

Life at Ascendis Pharma

Thrive Here & What We ValueCollaborative work environment | Opportunities for professional growth and development | Flexible work schedule options | Recognition for outstanding performance</s> | Fast-growing global biopharmaceutical company committed to making a meaningful difference in patient's lives | Guided by core values of Patients, Science, and Passion | Use TransCon® drug development platform to fulfill mission of developing new therapies | Advancing programs in Endocrinology Rare Disease and Oncology | Collaborating with partners around the world on the development of TransCon-based products for other therapeutic areas and markets | Seeking passionate People Leader to join growing function | Part of People Leader community with three People Leaders based in Hellerup and Princeton, US | Responsible for well-being and personal development of team members in Denmark | Work closely with Lene Rhein Larsen, People Leader, to continuously improve governance and people processes | Report to Lars Tranberg Pettersson, CIO and work out of our Hellerup office.</s> | Dynamic Workplace for Employees to Grow and Develop Their Skills | TransCon® Drug Development Platform to Fulfill Mission of Developing New and Potentially Best-in-class Therapies to Address Unmet Medical Needs | Exceptional Science, Visionary Leadership, and Skilled and Passionate Colleagues | Collaborative Environment for Skilled, Adaptable, and Highly Resourceful Professionals to Make Their Mark</s> | 1. Entrepreneurial and international company | 2. Short line of command | 3. GCP & GVP regulated environment | 4. Exciting product pipeline | 5. Highly skilled and experienced colleagues</s> | Collaborative culture on an accountability-based team | Unique offerings of Pet Insurance and Legal Insurance | Employee Assistance Program | Employee Discounts | Professional Development | Health Saving Account (HSA) | Flexible Spending Accounts | Various incentive compensation plans | Accident, Critical Illness, and Hospital Indemnity Insurance | Mental Health resources | Paid leave benefits for new parents</s> | 1. Guided by our core values of Patients, Science, and Passion | 2. Use our TransCon® drug development platform to fulfill our mission of developing new therapies, selecting only those that demonstrate bestin-class potential to address unmet medical needs. | 3. Advancing programs in Endocrinology Rare Disease and Oncology. | 4. Collaborating with partners around the world on the development of TransConbased products for other therapeutic areas and markets.</s> | 1. PatientCentric Approach | 2. ScienceDriven Innovation | 3. Passionate Team Members | 4. Collaborative Environment | 5. Dynamic Role</s> | Use TransCon® drug development platform to fulfill mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs | Collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets</s> | Fast-paced environment with cross-functional, global teams | Collaborative, international and informal environment where we challenge and learn from each other</s> | Patient-centric, science-based, performance-driven | Creating an outstanding workplace</s> | Patient-centric approach to drug development | Emphasis on innovation and scientific excellence | Collaborative work environment with opportunities for professional growth | Focus on making a meaningful difference for patients through our innovative TransCon technology platform | Strong commitment to employee well-being and work-life balance</s> | Visionary leadership</s> | Fostering a place where skilled, adaptable, and highly resourceful professionals can truly make their mark | Using TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs | Advancing programs in Endocrinology Rare Disease and Oncology</s> | Dynamic, fast-growing global biopharmaceutical company | Onsite presence in our Palo Alto, CA office 3 times per week or more, as necessary | Travel within the US &/or to our corporate headquarters in Denmark may be necessary | Focuses on exceptional science, visionary leadership, and skilled and passionate colleagues. | Uses TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs. | Fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. | Offers dynamic workplace for employees to grow and develop their skills.</s> | Culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark.</s> | Dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States | Providing strategic leadership to ensure the successful design and execution of non-clinical and clinical trials as well as Life Cycle Management Strategies | Engaging closely with internal peers and externally stakeholders such as the FDA, EMA, and other key regulatory bodies | Formulating strategies, enhancing performance, implementing relevant policies, and providing key insights that enable the organization to operate collaboratively and proactively.</s> | Fast-growing biopharmaceutical company with locations in Denmark, United States, Germany, United Kingdom, Italy, Spain, and France | Applying innovative TransCon technology platform to build a leading, fully integrated biopharmaceutical company | Diverse pipeline designed to make a meaningful difference for patients | Started launching Endocrinology Rare Disease portfolio globally, in the US, Germany & Austria, with plans for rapid expansion</s> | Passionate about patients and science | Collaborative mindset | Diverse workforce offers a more personal understanding of our customers' needs and concerns | Trusting and appreciative company culture | Value colleagues of diverse backgrounds and their abilities to contribute unique viewpoints and perspectives to all aspects of the business, from drug development to marketing.</s> | Unique Ascendis DNA: flat hierarchies, short lines of communication, and a dynamic, open, and informal working atmosphere | Tremendous opportunity to make an impact | Great team and corporate events | Attractive base salary, sponsored pension scheme (bAV), paid internet, exciting short- and long-term incentives | Structured onboarding program | Tailor-made training and development opportunities embedded in a well-resourced training budget | Direct connection to tram station, parking lots for cars and bikes | Soft drinks and wide variety of snacks | State-of-the-art workplace with iPhone, iPad, and brand-new laptop.</s> | Unique Ascendis DNA: flat hierarchies, short lines of communication, dynamic working atmosphere, tremendous opportunity to make an impact, great team and corporate events | Structured onboarding program, tailor-made training and development opportunities embedded in a well-resourced training budget | State-of-the-art workplace with iPhone, iPad, and brand-new laptop</s> | Collaborating with partners around the world on the development of TransCon-based products for other therapeutic areas and markets.</s> | Passionate about training and development — and ready to build something from the ground up | Patients, Science, and Passion core values | Adaptable and highly resourceful professionals can truly make their mark</s> | Fast-paced, cross-functional environment where your coordination skills drive real impact | Innovative treatments for rare diseases while growing commercial experience | Commitment to making a meaningful difference in patient’s lives | Use TransCon® drug development platform to fulfill mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs.</s> | Fast-growing global biopharmaceutical company committed to making a meaningful difference in patient’s lives | Collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets.</s> | Collaboration with cross-functional, global teams working together to achieve extraordinary results | Informal, open environment where innovation and change are key</s> | Collaborating with cross-functional, global teams working together to achieve extraordinary results | Entrepreneurial, informal, and open environment where innovation and change are key | Passionate about helping Commercial organizations gaining full value of their applications | Committed to making a meaningful difference in patients’ lives</s> | Collaborates with cross-functional scientific affairs team members to ensure that scientific standards are aligned across the organization | Stays current with industry trends, disease state areas, and treatment guidelines that impact training content | Offers employee discounts and mental health resources | Provides paid leave benefits for new parents</s> | Commitment to making a meaningful difference in patient's lives | Key strategic endeavour by Ascendis to expand global footprint in partnership with indirect affiliates across the globe</s> | Collaborating with cross-functional partners to identify and respond to local opportunities and customer needs</s> | Uses TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs</s> | TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs | Commitment to advancing our Medical Affair’s teams’ scientific knowledge and skills, while making a significant impact in the lives of our patients</s> | Dynamic environment | Opportunity to develop skills and knowledge within the team | Flexible working hours to accommodate study and work</s> | Use TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs</s> | Diverse pipeline designed to make a meaningful difference for patients</s> | Fast-growing global biopharmaceutical company committed to making a meaningful difference in patients' lives | Exceptional science, visionary leadership, and skilled and passionate colleagues</s> | Fast-growing biopharmaceutical company with locations in Denmark, United States, Germany, United Kingdom, Italy, Spain, and France</s> | TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies</s> | Collaborative environment with strong relationships between internal team and external partners | Inclusive environment for all employees</s>

Senior Specialist, Drug Product QC

Description

Your key responsibilities will be:

Qualifications and Skills:

Furthermore, it is an advantage if you have experience with:

Key personal competencies:

Life at Ascendis Pharma

Your tracker settings

Qualifications and Skills: 

Furthermore, it is an advantage if you have experience with: 

Key personal competencies: 