Date Posted:

1/24/2012

 

Job ID:

1747

 

Company:

Company combines their own cancer biology program with drug research development and commercial proficiency in its attempt to discover and develop targeted cancer therapeutics. Driven by our dedication to revolutionary science, our passion for drug research and development and craving to optimistically impact patients’ lives, We are moving swiftly to transport momentous new treatments to the medical oncology community and their patients.

 

Location:

MA

 

Reports To:

VP CORP.

 

Salary:

6 figures

 

Education:

Bachelor’s degree in relevant field required.

 

Requirements:

Requires at least 8 years industry experience, with a minimum 3 years in oncology sales training. Prior experience launching new product(s) in specialty markets. Experience with best-in-class means of training delivery including eLearning, self-study, assessment, audio/video, classroom and experiential learning to ensure the sales force is trained and is able to deliver the attributes of our products. Demonstrated success in managing numerous projects simultaneously. Partnership experience is a plus.

 

Duties:

In this newly created position, Director/ Sr. Director of Training is responsible for building of the Sales Training organization, developing all training programs and delivering sales materials to the field sales force. This will include product knowledge, competitive product analysis and differentiation, sales force effectiveness for sales processes and compliance requirements, business plan development with success metrics and requirements for note-taking & records retention. This position will support corporate training initiatives to ensure compliance with OIG guidelines. The incumbent will develop and facilitate all areas and phases of sales training including on-going field needs, managers meetings, plan of action meetings and product launches. Collaborative work with Sales, Marketing, Legal, HR, Regulatory, Medical and Operations is essential to deliver effective sales training programs. Lead and develop training around launch plans for US Sales and Marketing teams to ensure consistency in launch readiness including development of product and non-product training modules for new oncology sales team. Design and execute product and non-product training for sales specialists and sales management team in collaboration with internal stakeholders, partners and external vendors. Lead and coordinate new hire training programs for Sales and Commercial Operations. Lead efforts in launch and other company meeting planning and execution, including site and production vendor selection, agenda creation, workshop development and delivery as well as overall meeting facilitation. Build the Sales Training organization, staff as appropriate, set direction through the performance management process and develop team. Partner and collaborate with Marketing to develop sales force strategies to ensure product success in the marketplace. Identify, evaluate and manage vendors to support training. Establish goals and learning objectives to design appropriate and effective curricula, utilizing principles of adult learning. Leverage technology to promote cost effective remote training using company LMS system. Partner with Sales Management to develop and administer sales force development plans and performance evaluations. Perform additional responsibilities and participate in special projects as assigned. Collaborate with companys commercial corporate partner to achieve consistent and compelling materials and programs in a compliant and effective manner. Lead training sessions that focus around selling skills, clinical study reviews, clinical case studies, competitive overviews, account management and OIG guidelines for compliance, etc. Aid in cross functional training to other functional areas, such as Marketing, Clinical and Corporate. Partner and work with the Regional Business Directors, Managed Care Directors and Clinical Sales Specialists in their territories to provide coaching and feedback for development and for assisting in driving sales. Conduct regular conference calls with Sales leaders and Specialists to cover recent clinical information and enhance selling opportunities. Develop programs and gap assessment tools for use at regional meetings to aid in continued development of the Sales Specialist skill and knowledge base. Incorporate all required regulatory and legal compliance programs into the appropriate training programs.

 

Date Posted:

1/17/2012

 

Job ID:

1743

 

Company:

We are a specialty wire manufacturer. Our company serves the medical, commercial, and orthodontic industries with the manufacturing of surgical staples and orthodontic hardware. We also service the automotive industry, HVAC, lighting and power tools with such items as compression, extension, and torsion springs.

 

Location:

New England N.E.

 

Reports To:

Director, QA & Regulatory Affairs

 

Salary:

90k to 110k

 

Education:

Degree in the life sciences

 

Requirements:

Lean, SPC, PFMEA, Risk Management, Validation, CGMP, Internal Auditing, ISO 9001, ISO 13485 & MDD93/42EEC and MHLW No. 169. Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics. Project Management - Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities. Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others. Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others ideas and tries new things. Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings. Directly supervises two employees in the Quality Control-Orthodontics Quality Control-MCA. Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

 

Duties:

Designs, implements and maintains Quality Assurance system documentation to ensure consistency of quality in production and concurrence with regulatory requirements. Oversee quality processes, performs analysis, develops procedures, and writes protocols. Designs and implements systems to assure quality of production processing across multiple sites. Serves as liason/team member with regulatory affairs, research and development, and manufacturing departments. Helps develop documents to support compliance with the quality assurance program and Good Manufacturing Practice (GMP), and documents method and validation development. Visit and confer with representatives of vendors to obtain information related to supply quality, capacity, of vendor to meet orders, and vendor quality standards. Confer with the applicable departments about quality assurance of new products to ensure product quality. Confer with the applicable departments for manufactured products on the market to rectify problems. Designs, implements and maintains quality assurance system documentation for the assurance of conformity to customer, quality management system standards, and applicable statutory and regulatory requirements. Investigate customer complaints, perform root cause analysis, identify corrective and preventive action, and prepare reports for custmer submission. To discontinue further processing and delivery of non-conforming products until the discrepancy or non-conforming condition has been corrected. To initiate actions to prevent the occurence of non-conformity Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information. Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyones efforts to succeed. Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results. Delegation - Delegates work assignments; Matches the responsibility to the person; Gives authority to work independently; Sets expectations and monitors delegated activities; Provides recognition for results. Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others. Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates activities; Makes self available to staff; Provides regular performance feedback; Develops subordinates skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills. Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness. Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals. Cost Consciousness - Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue ; Conserves organizational resources. Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values. Judgement - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions. Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans. Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments. Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events. Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals.; Completes tasks on time or notifies appropriate person with an alternate plan. Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed. To perform this job successfully, an individual should have knowledge of Outlook Contact Management systems; Excel Spreadsheet software and Word Word Processing software.

 

Date Posted:

1/12/2012

 

Job ID:

1742

 

Company:

Company combines their own cancer biology program with drug research development and commercial proficiency in its attempt to discover and develop targeted cancer therapeutics. Driven by our dedication to revolutionary science, our passion for drug research and development and craving to optimistically impact patients’ lives, We are moving swiftly to transport momentous new treatments to the medical oncology community and their patients.

 

Location:

Cambridge

 

Reports To:

Director Manufacturing

 

Salary:

compensatory with exp.

 

Education:

MS in chemistry, biology, chemical engineering or equivalent.

 

Requirements:

The ideal candidate has significant experience developing recombinant mammalian cell culture processes for manufacture, and scaling cell culture and standard downstream purification techniques to produce biopharmaceuticals in-house and at contract manufacturing organizations. Additional responsibilities will include contributing significantly to the design and creation manufacturing infrastructure, such as operating procedures, technology transfer systems, and data bases. 5 years experience supporting the manufacturing of drug substances derived from mammalian cell culture and purified by chromatography and membrane technologies. 3 years contract manufacturing experience and relationship management. Applied process development and process optimization skills. Familiarity with FMEA, DOE, process characterization methods. Strong analytical and molecular characterization knowledge and experience. Superior written and verbal communication skills and presentation skills. Experience managing process data and analysis to support process design. Excellent document preparation and review skills. US and EU facility and process validation and compliance expertise . Knowledge of contracting business systems and agreements. Ability to travel 20% of time.

 

Duties:

Overview: Reporting to the Director of Manufacturing, this position will oversee process development, tech transfer, clinical manufacturing and process validation of monoclonal antibody drug substances at contract manufacturers. The incumbent will evaluate the process and direct development activities focused on process comparability, process optimization, commercial viability and regulatory compliance.