$80K — $100K *
Technical Development Sr. Manager
The Technical Development Sr Manager (TDM) will provide pre-sale technical support in presentations and product demonstrations. The TDM will work closely with Engineering, Manufacturing, R&D, and Marketing to meet the customer needs / improvements / expectations and in the development of new products for customers.
1. Business development
• Develop excellent relationships with customers to convey support and confidence with regards to the company’s capabilities, service and product offering.
• Provide hands-on technical knowledge and support from clinical development through the market launch to customer (internal and external stakeholders).
• Interface with Product Development, Marketing, Production, Engineering, Manufacturing, R&D, QA, QC and Regulatory with respect to scale-up, technology transfer, process validation, and marketed product support of new, reformulated, and commercial products. Interact on all levels with external customers for all related activities. Manage and facilitate product technology information flow.
• Maintain up-to-date knowledge of GMP regulatory issues particularly pertaining to parental drug delivery and ensure that company Technical Services policies and procedures are current.
• Contribute information to technical service and business development strategies by evaluating current product results, identifying needs to be fulfilled, monitoring competitive products, and analyzing and relaying customer feedback.
• Detect and analyze changes in market environment and promptly respond to resulting changes in customer needs.
• Present case studies, scientific and technical research topics to small and large audiences at international conferences.
• Responsible to follow Quality system requirements, including but not limited to, providing guidance and training of associates in Quality system regulations and the understanding of all Quality system processes.
• Coordinate & follow up of improvement processes (including CAPA’s) together with the related departments.
• Establish and generate appropriate Executive and detailed reports to serve all constituents.
• Follow and monitor the progress in standardization work (ISO, EN, IEC) applicable to the medical devices.
• Ensure all technical services activities comply with company policies and all applicable laws.
3. Customer Support
• Develop new applications by preparing specifications, conferring with product engineering.
• Develop and design equipment based upon the customer needs.
• Provide support to all Account Managers according to the accounts and regions assigned.
• Implement best practice at customer sites.
• Give product, technology or any other training based on customer needs.
• Engineering field support.
• Review of different types of technical documentation.
• Technical documentation preparation for our products (specifications, drawings, position papers).
• ISO TC 76 and TC 84 coordination and participation as required.
• Functionality testing.
• Conversion of data to pitch pack.
• Foster teamwork, build relationships, people skills, initiative, customer focus.
• Seek quality results and continuous improvement opportunities.
6. Other duties as assigned
To be successful in the position extensive national and international travel is required. It is fair to state that a minimum of 25% travel is to be expected. The applicant must be holder of a valid international passport and a driving license.
Knowledge, Skills and Abilities
• Dedicated to meet the expectations and requirements of internal and external stakeholders.
• Ability to manage multiple projects within limited timelines.
• Ability to deal with ambiguity and different business cultures.
• Demonstrated expertise in drug information communication
• Knowledge of FDA, EMA, OIG requirements
• Strong understanding of clinical trial design and biostatistics.
• Knowledge of packaging and/or medical product manufacturing and development
• Knowledge of scale-up and technology transfer to commercial manufacturing site
• Working knowledge of fill/finish equipment and processes, aseptic processing, product and process validation, quality systems, FDA/EMEA regulatory requirements for medical devices and/or pharmaceutical products
• Demonstrates daily that his/her decisions are made in the best interests of the company and the customer
• Deep understanding and sensitivity to the cultures of global organizations
• Strong interpersonal and communication skills and ability to interact at all levels of the organization
• Possesses excellent analytical and problem-solving skills
• Excellent planning, organizational, and project management skills
• Strong technical business writing and oral presentation skills
• Master’s degree in Chemical or Biomedical engineering, pharmaceutical sciences, or related field required.
• 8+ years of experience in pharmaceutical or medical device industry.
• Experience in sterile manufacturing processes and packaging.
• Excellent analytical and problem-solving skills
• Excellent planning, organizational, project management skills
• Strong technical business writing
• Fluent in English (written and spoken). Other languages are an asset.
• Must be proficient in Microsoft Word, Excel, PowerPoint, and Outlook
• Internationally oriented, willing to travel globally as required (up to 50%)
Valid through: 4/23/2021
$80K — $100K
6 days ago