Reports to: Development Scientist II, Bioanalytical Development
Location: Cheshire, CT
Alexion is a biopharmaceutical company focused on serving patients with severe and rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition and has developed and markets Soliris® (eculizumab) as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in nearly 50 countries for the treatment of PNH, and in the United States, European Union, Japan and other countries for the treatment of aHUS. Alexion is evaluating other potential indications for Soliris in additional severe and ultra-rare disorders beyond PNH and aHUS, and is developing other highly innovative biotechnology product candidates across multiple therapeutic areas. Further information about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com .
Position Summary
The BA CRO Study Monitor (Development Associate IV-DAIV) is a scientist in Alexion’s Bioanalytical Development who oversees and monitors bioanalytical assays (method development, validation, sample analyses) at CROs. BA CRO Monitors are generally assigned when the BA PI is located at CRO and/or analyses are performed at a CRO. Their responsibilities include facilitation of assay development and validation of assays for pharmacokinetics, pharmacodynamics and anti-drug antibodies, in a regulated environment. It also includes evaluating the need for comparable assays (comparable format and/or comparable performance) to those qualified/validated at Alexion. While they will be coordinating technical evaluation of assays at CROs, regardless of the platform, the primary analysis platforms include ELISA, MSD, RT-PCR and LCMSMS technologies. A major aspect of this work is diligence in documentation and compliance with current department SOPs, GLP and regulatory guidelines. This position will have a heavy emphasis on interacting with contract research organizations (CROs) and guiding method development, validation, and sample analysis at CROs. The BA CRO Monitor will attend bioanalytical sub-team team meetings led by Bioanalytical Project Leaders to communicate information on prioritization, tasks, and timelines on assays being developed and validated at CROs. The BA CRO Monitor will be capable of solving technical issues and work closely with the head of external outsourcing on resolving logistical, and contractual issues at CROs with excellent communication skills.
Principal Responsibilities
Leads regular interactions with CROs to facilitate method development, validation, and sample analysis activities
Uses strong communication skills to negotiate technical details and timelines, in conjunction with the head of external outsourcing, to provide guidance to CROs; strives to achieve project deadlines, in conjunction with the head of external outsourcing. Effectively holds vendors accountable for high quality data and associated timelines
Able to effectively and clearly communicate across departments in timely fashion, in conjunction with BA Project Leaders
Works closely with the head of external outsourcing to help maintain detailed communication log, trackers, and list of activities at CROs to ensure project timelines are met
Have a clear and comprehensive understanding of Alexion procedures related to outsourcing and vendor management; work closely with and support the head of external outsourcing to apply these procedures to effectively manage CROs
Work closely with and provide support to the head of external outsourcing CROs to ensure contracts and purchase orders are in place and in alignment with study plans and protocols
Plan and organize study-related logistics such as sample shipment, writing laboratory manuals, ordering laboratory supplies and, as needed, procuring reagents for CROs
Escalate, when technical or logistical issues necessitate, to GCPL of BA Project Leader (BAPL) or head of external outsourcing or management as appropriate
Attend BA sub-team meetings as the BA CRO Monitor, and, if requested, serve as the interim Bioanalytical Project Lead
Engage in discovery and/or development projects leading to qualification/validation of fit-for-purpose bioanalytical assays at CROs in multiple matrices including serum, plasma and urine.
Design and execute work to be performed at CROs, using established methods, with an understanding of the timelines and how the activities fit into a larger project frame
Works on projects with a complex scope in which analysis of assay variables, procedures or data requires a review of critical factors. Exercises judgment within defined procedures and practices to determine appropriate bioanalytical action.
Investigate, create and develop new technologies/methods at CROs
Ensure that CROs follow GLP for regulated sample analyses
If laboratory scientist resource are needed in BA Development , serve as a laboratory bench scientist and technical expert on lab instrumentation, software and/or assay development, validation, documentation and/or study protocols
Adhere to GLP/GCP guidelines for work performed at CROs
Maintains high level of technical bioanalytical expertise through familiarity with scientific literature.
Qualifications
Hands-on experience with developing and validating assays for large molecule/protein and antibody therapeutics in biological fluids in the GLP setting
Hands-on experience analyzing samples for large molecule/protein and antibody therapeutics in biological fluids the GLP setting
Able to demonstrate lab skills and be the resource of routine lab procedures
Experience working with CROs and ability to facilitate Sponsor-CRO interactions.
Experience with ligand-binding assays including ELISA and MSD; willing and able to quickly learn new techniques
Highly organized and capable of handling multiple tasks/projects simultaneously.
Excellent organizational skills and ability to prioritize tasks based on project timelines.
Excellent verbal and written communication skills as well as technical writing.
Strong documentation and inter-personal skills and willingness to collaborate with colleagues at the bench and on project teams.
Familiar with standard bioanalytical laboratory instrumentation and software including MSD benchtop and Softmax PRO.
Able to execute routine work independently and perform assigned tasks
Can solve routine to moderately complex problems
Education
BS degree with 4-8 years’ experience or MS with a minimum of 2-4 years’ experience in bioanalytical chemistry or other relevant biological sciences
Competencies
Development Associate IV:
Experience & Know-How: A seasoned, experienced professional with a good understanding of area of specialization; resolves a range of issues. This job is for a qualified, career-oriented, bioanalytical scientist with experience in managing scientific work at CROs. Normally requires a university degree and 4-8 years related experience. At this level, post-graduate coursework may be desirable. Demonstrated ability to be a technical resource.
Complexity & Scope: Works on complex bioanalytical issues where analysis of situations or data requires an in-depth evaluation of critical variables. Networks with key contacts outside own area of expertise. If needed, draft and revise SOPs and other important documents. Makes process improvement recommendations.
Decision Making & Accountability: Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead). Plans and executes all of their own work. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
Collaboration and Communication: Able to communicate, collaborate, and negotiate across departments within Alexion with Global Clinical Pharmacology Leaders, BA Project Leaders and externally with CROs. Can facilitate a complex team or group of individuals to arrive at a solution or conclusion based on review of data and goals. Can act as a single point of accountability for CRO engagement. The incumbent should be able to collaborate with colleagues, The incumbent should be able to effectively deal with diverse groups and know exactly how to build brigdges between different kinds of people and always takes times to listen and learn in unfamiliar situations. The incumbent should be adept at negotiating across departments within and outside Clinical Pharmacology and should be highly skilled at dealing with external CROs. Also able to communicate clearly and concisely with CROs about the technical and administrative details of assays. Can facilitate meetings and teleconferences to push for and arrive at effective solutions to complex problems. Can act as a dual point of accountability for CRO engagement with oversight from the head of external outsourcing
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer
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