Manufacturing Manager Durata Therapeutics, Inc.
The Manufacturing Manager is responsible for all aspects of commercial parenteral drug product manufacturing and supply of US finished goods. This includes managing Contract Organization?s (CO?s) to meet forecast and inventory requirements and leading or supporting technology development programs. Key responsibilities of this role include CO selection and management, production scheduling, parenteral drug product / finished good batch review for release, commercial labelling control, parenteral drug product development, and project management.
As a growing and virtual company, Durata is designing, implementing and optimizing our supply chain processes and vendor management activities. This individual will play a key role in defining supply chain roles and processes to ensure we are GMP compliant, manage CO?s effectively, and develop products to meet life-cycle management requirements. This individual may also assist in a variety of other commercial, quality, operations, or development activities as required. This role will be required to travel domestically and internationally at least 25%.
Manage business aspects related to parenteral drug product contractors and suppliers; e.g., selection, contracting, management, and cost control.
Serve as primary contact with drug product CO?s; resolve business and technical issues efficiently and cooperatively.
Partner with planning personnel to schedule production at CO?s to maintain desired inventory levels in support of S&OP processes.
Partner with Quality to review CO batch records, deviation reports, risk assessments, and CAPA?s; and ensure drug product and finished goods comply with registered specifications and processes.
Partner with Quality to ensure CO?s comply with GMP?s and Quality Agreements; manage process and/or documentation changes in a controlled manner; and assist in preparation of annual product reviews.
Coordinate/implement changes to US commercial labeling, as required.
Lead and support parenteral drug product technology programs, which may include: formulation development, process optimization, component sourcing and qualification, or technical transfer to an alternate CO.
Help organize and provide reports or data for Regulatory communications/dossiers.
Comply with internal Quality policies and procedures; support, draft, comply with Supply Chain policies, procedures, or work practices; monitor new/emerging regulatory requirements for sterile manufacturing.
Support return good, complaint, and recall investigations, as required.
Support clinical development; ensuring bulk drug product is available as required.
Interface with other Company functions as required; e.g., Regulatory, Medical Affairs, Quality, Clinical Supply, Finance, Commercial, Legal.
Bachelor?s degree in a relevant scientific discipline is required
Master?s degree in a relevant scientific discipline or business management is preferred
REQUIRED SKILLS AND EXPERIENCE:
Minimum 5-8 years of experience developing or manufacturing small volume parenteral products
Knowledge of relevant sterile manufacturing processes and equipment
Knowledge of GMP/ICH regulations and guidelines
Experience managing major third party relationships and contracts
Experience with international supply chains
Experience with new product introductions
Experience developing Quality Systems and related SOP?s desired
Experience preparing or supporting FDA/EMA regulatory dossiers
Computer proficiency in Word, Excel, MS Project
Demonstrated leadership abilities with excellent communication, project management, negotiation and interpersonal skills
Self-starter with the ability to work effectively and independently
Ability to diagnose issues, solve problems and provide solutions
Ability to work well in small teams and with other cultures
Willingness to travel 20-25% required (occasionally outside the US)
ABOUT DURATA THERAPEUTICS
Durata Therapeutics is an equal opportunity employer welcoming diversity in our workforce.
Durata Therapeutics, Inc. is a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. Durata is developing its advanced-stage lead product candidate, dalbavancin, for the treatment of patients with acute bacterial skin and skin structure infections.
||Branford, CT |