Kelly Science&Clinical, for a multisite pharmaceutical company, is looking for a:
Sr. Biologics Engineer II PIP
This position is responsible for providing technical expertise and leadership to drive seamless technology transfer and process validation activities for Biologics and Anti-body Drug Conjugates (ADCs).
The Sr Engineer will engage and work with both internal (drug substance/product/process development teams) and external partners (CMOs) to support on-site clinical or commercial manufacturing campaigns.
The individual will support execution of on-going manufacture that may be used for validation strategies, qualifying manufacturing unit operations and sites to ensure supply plan meets the regional demand forecast and MOH targets. The individual will also serve as a key process support in GMP production on-site by providing technical leadership during manufacture and quality investigations of complex deviations/non-conformances. The Sr Engineer is expected to work closely with Technical Operations team in preparation/coauthoring reports to support regulatory filings (CTAs, BLAs, CBE and PAS) and addressing issues associated with CMC actionable complaints.
This position requires hands on individual with a proven record of accomplishment in managing complex manufacturing execution systems, excellent/effective communication and people skills.
* To perform hands-on support on manufacturing floor with Drug Substance and Drug Product processes of commercial and clinical material within external CMO for Biologics and Anti-body Drug Conjugates (ADCs).
* Serve as liaison between HQ and CMO partner to ensure production and manufacturing functions continuously to meet high demand. This includes monitoring supply on site and ensuring execution on manufacturing floor.
* Cultivate excellent working relationship with stakeholders to deliver successful manufacturing campaigns.
* Represent Global Biologics Technical Services on project core teams and sub-teams as a Subject Matter Expert (SME) to coordinate multi-functional activities relating to clinical and commercial drug substance and drug product manufacturing processes.
* Support to ensure on site regulatory inspection readiness and product compliance with regional regulatory requirements.
* Partnering with product development, manufacturing, quality and regulatory, to support on site manufacturing and investigations to address OOS, OOT, complex deviations/non-conformances and implement change controls to ensure timely/prompt release of batches to meet regional demand forecast and support CAPAs to be in place .
* Communicate manufacturing process lifecycle milestones and relate to project timelines.
* Maintain strong knowledge of GMPs and manage external CMOs.
* Collaborate with process and pharmaceutical development to deliver manufacturing processes that meet the speed, yield and product quality requirements of the development programs.
* Perform critical data review and provide directions for troubleshooting and investigation.
* Demonstrate hands-on technical leadership in the laboratory, oversee and delegate experimental/project responsibilities as needed.
* Perform other duties as required.
Knowledge & Skills:
* Ph.D. in Biological Sciences, Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or relevant field is preferred.
* Experience in managing complex manufacturing execution systems including tech transfer, process characterization, process validation of biological products is highly desirable.
* Process development and operations experience/expertise in drug product manufacturing processes including bulk freeze/thaw, mixing/pooling, filtration, filling and lyophilization.
* General understanding protein structure and its modes of degradation under various processing conditions.
* Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
* Excellent and effective verbal and written communication skills (English and Italian).
Job Location: Rome
The company offers:
Level of Pharmaceutical CCNL depending on candidate experience
Kelly Services S.p.A., iscritta in data 26/11/2004 nell'Albo Informatico delle Agenzie per il Lavoro, Sez. I., prot. n. 1098-SG. I candidati ambosessi (L. 903/77) sono invitati a leggere sul sito www.kellyservices.it l'informativa sulla Privacy (Regolamento UE 2016/679).
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.